CN111447885A - Systems and methods for bone fixation using staples locked to surrounding anchors - Google Patents

Abstract

Systems and methods for fixation of bone using an intramedullary nail locked to a surrounding anchor including a sleeve and a locking member. An exemplary system may include any combination of a nail, one or more sleeves, one or more locking members, a device to guide the installation of a sleeve, at least one drill, and a driver attached to a sleeve. The instrument may define a guide axis and be configured to be coupled to a bone such that the guide axis extends across the bone. The instrument may be used to guide a drill, a cannula and/or a locking member into a bone along a guide axis. The nail may be configured to be placed along an intramedullary canal of a bone such that the nail extends through the cannula, and the locking member may be configured to lock the nail to the cannula.

Description

Systems and methods for bone fixation using staples locked to surrounding anchors

CROSS-REFERENCE TO PRIORITY APPLICATIONS

This application is based on U.S. provisional patent application serial No. 62/569,955 filed 2017, 10, 9 and claiming the benefit of U.S. provisional patent application serial No. 62/569,955 filed 2017, 10, 9, in accordance with 35 u.s.c. § 119(e), which is incorporated herein by reference in its entirety for all purposes.

Introduction to the design reside in

An Intramedullary (IM) nail is an internal fixation device that may be placed along the medullary canal of a fractured bone. The nail acts as a splint within the bone to keep the various segments of bone aligned as healing occurs. A standard double-locking nail (double-locking nail) defines a plurality of apertures (apertures) near its opposite ends to receive screws that lock both ends of the nail to the bone. However, some bones, such as the fibula and ulna, may be too narrow to receive a standard nail without over reaming (reaming). For these bones, a single-locking nail (single-locking nail) of an elongated shape may be installed instead. A single locking nail has a head defining an aperture for the screw and a shank that is too thin to receive the screw. Thus, one end (head) of the nail is locked to the bone, but the other end (stem) remains unlocked. The nail may allow the bone segments to move relative to each other if the bone breaks at the location spanned by the shaft. For this type of fracture, if the surgeon chooses to lock the shaft to the bone as well, the bone may be stabilized more effectively.

U.S. patent No. 7,785,326 proposes a staple-based fastening system in which a staple extends through and locks to a fastener. More specifically, the system utilizes a mounting fixture that requires the nail to travel along a linear path during advancement into the bone until the leading end of the nail has entered the fastener hole. However, such systems are not suitable for locking the shaft of a non-linear and/or flexible nail to the bone at a considerable distance from the site where the nail enters the bone.

SUMMARY

The present disclosure provides systems and methods for fixation of bone using intramedullary nails locked to a surrounding anchor (encirclinaganchor) including a sleeve and a locking member. An exemplary system may include any combination of a nail, one or more sleeves, one or more locking members, a device to guide the installation of a sleeve, at least one drill, and a driver attached to a sleeve. The instrument may define a guide axis and be configured to be coupled to a bone such that the guide axis extends across the bone. The instrument may be used to guide a drill, a cannula and/or a locking member into a bone along a guide axis. The nail may be configured to be placed along an intramedullary canal of a bone such that the nail extends through the cannula, and the locking member may be configured to lock the nail to the cannula.

Brief Description of Drawings

Fig. 1 is a front view of a fractured left fibula (shown in phantom) secured with an intramedullary nail locked to a surrounding anchor, but omitting fasteners for the tail region of the nail, according to aspects of the present disclosure.

Fig. 2 is a side view of the broken left fibula of fig. 1 taken with the tack and surrounding anchor installed as in fig. 1.

Fig. 3 is a partial isometric view of the tack of fig. 1 and surrounding anchor, taken about the anchor.

Fig. 4 is a partial view of the fibula, tack and anchor of fig. 1, taken generally about the area indicated in fig. 1, with the fibula cut longitudinally.

Fig. 5 is a partial cross-sectional view of the staple and anchor of fig. 1 taken along line 5-5 of fig. 4.

Fig. 6 is a side view of the cannula of the anchor of fig. 1.

Fig. 7 is another side view of the cannula of fig. 1 taken along line 7-7 of fig. 6.

FIG. 8 is an end view of the cannula of FIG. 1 taken along line 8-8 of FIG. 6.

Fig. 9 is a cross-sectional view of the cannula of fig. 1 taken along line 9-9 of fig. 6.

Fig. 10 is another cross-sectional view of the cannula of fig. 1 taken along line 10-10 of fig. 8.

Fig. 11 is a side view of a locking member of the anchor of fig. 1.

Fig. 12 is a proximal end view of the locking member of fig. 1.

Fig. 13 is a cross-sectional view of the locking member of fig. 1 taken along line 13-13 of fig. 12.

Fig. 14 is a set of sleeves and corresponding locking members that may be included in the fixation system of fig. 1 to facilitate attachment of a nail to areas of bone having different local widths.

Fig. 15 is a partial cross-sectional view of the fibula of fig. 1, taken after the fibula has been drilled with a bi-cortical texture to prepare the bone to receive the cannula.

Figure 16 is another partial cross-sectional view of the fibula of figure 1, taken as in figure 15, except that a sleeve is implanted in the fibula.

Fig. 17-20 are a series of views of the nail and sleeve of fig. 1, with the nail shown in partial section and the sleeve shown in section as in fig. 9, taken as the tip of the nail is passed through the transverse aperture of the sleeve, and schematically illustrating how the offset of the tip and the rotation of the nail may cooperate to correct for misalignment between the tip and the transverse aperture, thereby allowing the tip to successfully enter the sleeve.

Fig. 21 is a partial front view of the fibula of fig. 1, taken during preparation of the fibula for receiving the cannula of fig. 1, and illustrating an exemplary instrument mounted in part to the fibula with a wire member (wire member) and positioned to guide a step drill (step drill), shown in part, into the fibula, in accordance with aspects of the present disclosure.

Fig. 22 is a top view of the instrument of fig. 21, taken without a guide portion of the instrument and with jaws of the instrument in a closed configuration.

FIG. 22A is a partial view of the instrument of FIG. 21, showing a portion of a gauge of the instrument.

Fig. 23 is another top view of the instrument of fig. 21, taken as in fig. 22, but with the jaws of the instrument in an open configuration.

Fig. 24 is a partial top view of the instrument of fig. 21, as taken in fig. 22 about the fulcrum and linkage assembly of the instrument.

Fig. 25 is another partial top view of the instrument of fig. 21, as taken in fig. 23 about the fulcrum and linkage assembly of the instrument.

Fig. 26 is a top view of the instrument of fig. 21 taken through the cortex and medullary canal of a fibula shown schematically in dashed outline.

Fig. 27 is a partial view of the instrument of fig. 21, taken as in fig. 26 and illustrating an exemplary trajectory in which the instrument may guide the leading end of the wire member into and/or through the bone to further couple the instrument to the bone to stabilize the instrument on the bone.

Fig. 28 is a schematic view corresponding to fig. 27, but showing a different exemplary trajectory in which the instrument may guide the leading end of the wire member into and/or through the bone to stabilize the instrument.

Fig. 29 is a schematic view of a pair of fluoroscopic images showing a partial axial portion of the fibula and nail of fig. 1, and the guide tube of the instrument of fig. 21, viewed along an axis defined by the guide tube before (left) and after (right) the position of the tube has been adjusted to improve alignment of the tube with the nail.

Fig. 30A is an isometric view of the guide portion and holder of the instrument of fig. 21, taken separately from the remainder of the instrument, with the guide portion in a locked configuration preventing rotation relative to the holder.

Fig. 30B is a partial isometric view of the guide portion and holder of fig. 30A, taken with the guide portion in an unlocked configuration that allows the guide portion to rotate relative to the holder.

Fig. 30C is another partial isometric view of the guide portion and retainer of fig. 30A, taken after the guide portion has been rotated relative to the retainer (as compared to fig. 30B) while the guide portion is still in the unlocked configuration.

Fig. 31 is a cross-sectional view of the guide portion and retainer of fig. 30A, taken generally along line 31-31 of fig. 30A and showing an alternative locking position of the guide portion in phantom.

Fig. 32 is a cross-sectional view of the guide portion and retainer of fig. 30A, taken generally along line 32-32 of fig. 30A.

Fig. 33A is an isometric view of another example guide portion and retainer for the instrument of fig. 21, taken separately from the remainder of the instrument, with the guide portion in a locked configuration that prevents movement relative to the retainer, according to aspects of the present disclosure.

Fig. 33B is another isometric view of the guide portion and retainer of fig. 33A, taken as in fig. 33A, except where the retainer is partial and where the guide portion is retracted to create an unlocked configuration.

Fig. 33C is another partial isometric view of the guide portion and retainer of fig. 33A, taken as in fig. 33B, except with the guide portion rotated, with the guide portion retracted and in an unlocked configuration.

Fig. 34 is a cross-sectional view of the guide portion and retainer of fig. 33A, taken generally along line 34-34 of fig. 33A.

Fig. 35 is another cross-sectional view of the guide portion and retainer of fig. 33A, taken generally along line 35-35 of fig. 33A.

Fig. 36 is an isometric view of yet another example guide portion and retainer for the instrument of fig. 21, taken separately from the remainder of the instrument, according to aspects of the present disclosure.

Fig. 37 is an exploded partial view of the guide portion and retainer of fig. 36.

Fig. 38 is a cross-sectional view of the pilot portion of fig. 36, taken generally along line 38-38 of fig. 36.

Fig. 39 is an isometric view of an exemplary drive for the cannula of fig. 14.

FIG. 40 is an exploded view of the driver of FIG. 39 with one of the sleeves of FIG. 14 aligned with the driver.

FIG. 41 is a partial view of the sleeve of the driver of FIG. 39, taken about the forward end of the sleeve and showing the projections mating with the complementary recesses of each sleeve.

FIG. 42 is a cross-sectional view of the driver of FIG. 39, taken generally along line 42-42 of FIG. 40 through a handle portion of the driver.

Fig. 43 is an exploded view of another example surround anchor for the staple-based fixation system of fig. 1, according to aspects of the present disclosure.

Fig. 44 is a side view of the cannula of the anchor of fig. 43 viewed parallel to the through axis defined by the transverse aperture of the cannula.

FIG. 45 is a side view of the bushing of FIG. 44 taken normal to the through axis of the transverse bore.

Fig. 46 is a side view of a locking member of the anchor of fig. 43.

Fig. 47 is a partial cross-sectional view of the anchor of fig. 43, taken generally along line 47-47 of fig. 43, wherein the anchor encircles and locks to an anterior region of the intramedullary nail of fig. 1.

Fig. 48 is a cross-sectional view of the anchor of fig. 43 at an early stage of assembly, taken generally along line 48-48 of fig. 43, with an anterior region of the intramedullary nail of fig. 1 extending through a sleeve of the anchor, and with a locking member of the anchor advanced translationally only into an axial opening of the sleeve and not yet in threaded engagement with the sleeve.

Fig. 49 is another cross-sectional view of the anchor and staple of fig. 48, taken as in fig. 48, except wherein the anchor is in an intermediate stage of assembly produced by rotational (threaded) advancement of the locking member into the axial opening of the sleeve such that the staple is partially advanced to the distal end of the transverse aperture of the sleeve.

FIG. 50 is another cross-sectional view of the anchor and staple of FIG. 48, taken as in FIG. 49, except with the locking member fully advanced to a seated position (seed position) locking the staple to the cannula.

Fig. 51 is a top view of another exemplary instrument for guiding installation of a cannula of an anchor (nail) surrounding a nail, according to aspects of the present disclosure.

Fig. 52 is a view of the guide portion and retainer of the instrument of fig. 51, taken separately from the clamp portion of the instrument.

Fig. 53 is a partial cross-sectional view of the guide portion and retainer of fig. 52, taken generally along line 53-53 of fig. 52.

Fig. 54 is another cross-sectional view of the guide portion and retainer of fig. 52, taken generally along line 54-54 of fig. 53.

Fig. 55 is a side view of an exemplary near-cortical drill (near-drill) for use in a two-drill procedure (two-drill procedure) for drilling a hole in bone to receive a cannula, wherein the near-cortical drill is configured to be guided into the bone using any of the guiding instruments disclosed herein.

Fig. 56 is a side view of an exemplary distal cortical drill that may be used with the proximal cortical drill of fig. 55 in a two-drill procedure to drill a hole in bone to receive a cannula.

Fig. 57-59 are partial cross-sectional views of a bone illustrating how the drill of fig. 55 and 56 may sequentially drill holes of different diameters to receive correspondingly sized regions of a cannula.

Detailed Description

The present disclosure provides systems and methods for fixation of bone using an intramedullary nail locked to a surrounding anchor comprising a sleeve and a locking member. An exemplary system may include any combination of a nail, one or more sleeves, one or more locking members, a device to guide the installation of a sleeve, at least one drill, and a driver attached to a sleeve. The instrument may define a guide axis and be configured to be coupled to a bone such that the guide axis extends across the bone. The instrument may be used to guide a drill, a cannula and/or a locking member into a bone along a guide axis. The nail may be configured to be placed along an intramedullary canal of a bone such that the nail extends through the cannula, and the locking member may be configured to lock the nail to the cannula.

An exemplary system for bone fixation is provided. The system may include an instrument, a cannula, a staple, and a locking member. The instrument may have a pair of jaws configured to engage opposite sides of the long shaft. The jaws may be coupled to a guide portion defining a guide axis. The guide axis may extend across the shaft when the jaws are engaged with the shaft. The instrument may be configured to maintain the guide axis in a central plane located between and equidistant from the jaws as the jaws open and close. The cannula may be configured to be placed transversely in the bone along the guide axis. The nail may be configured to be placed along a medullary canal of a bone such that the nail extends through the cannula. The locking member may be configured to lock the staple to the sleeve. In some embodiments, the instrument can be configured to allow the guide axis to be adjustably offset relative to the central plane, if desired. In some embodiments, the instrument may be configured to guide a wire member into/through a bone to couple the instrument to the bone. For example, the leading ends of a pair of wire members may be guided through the bone in non-parallel trajectories to stabilize the instrument on the bone. In some embodiments, the instrument may include a gauge configured to measure a local width of the bone, and optionally indicate whether the local width is sufficient for safe installation of the cannula. In some embodiments, the cannula may form a shoulder configured to prevent advancement of the cannula when the shoulder contacts the distal cortex of the bone. The sleeve may also form a post projecting distally from the shoulder. In some embodiments, the staple may have an offset tip configured to allow adjustment of the alignment of the staple with the transverse aperture of the cannula as the staple is rotated about its long axis.

An exemplary method of fixing a bone is provided. In this method, opposite sides of a bone may be engaged with jaws of an instrument having a guide portion defining a guide axis. The jaws may be coupled or configured to be coupled to the guide portion such that the guide axis remains in a central plane located between and equidistant from the jaws as the jaws open and close. At least one hole may be drilled transversely in the bone along the guide axis. The cannula may be placed into the bone at the at least one hole. The nail may be advanced along the medullary canal of the bone such that the nail extends through the cannula. The nail may be locked to the sleeve.

Another exemplary method of fixing bone is provided. In this method, the bone may be drilled along an axis to form a wider hole through the near cortex of the bone and a narrower hole in and/or through the far cortex of the bone. A cannula may be selected. The sleeve may have a tail portion with a diameter corresponding to the wider bore and a nose portion with a diameter corresponding to the narrower bore. The tail portion may form a shoulder adjacent the front portion. The cannula may be driven as a unit along the axis into the drilled bone until contact between the shoulder and the distal cortex prevents further advancement of the cannula. The nail may be advanced along the medullary canal such that the nail extends through the cannula. The nail may be locked to the sleeve.

The systems and methods of the present disclosure may provide any combination of the following features and advantages. The installation of the cannula may be performed more reliably using an instrument with a self-centering guide axis. The jaws of the jig may be inserted through the incision and under the soft tissue covering the opposite side of the bone to engage an area of the bone that is not visible to the surgeon. Thus, even if the surgeon is unable to visually determine where the transverse center of the bone is, the self-centering configuration of the instrument can ensure that the guide axis extends across the bone very close to the transverse center. Furthermore, the system and method can reliably align the leading end of the nail inside the bone with the transverse aperture defined by the cannula, even when the nail is flexible/curved and/or when the cannula is positioned away from the site of nail entry. The nail successfully mates with the cannula when the trajectory of the nail intersects the transverse aperture of the cannula. The system and method can correctly position the guide axis along which the cannula is installed. For example, as described above, the instrument defining the guide axis may be self-centering on the bone and/or may allow the guide axis to move off-center while the instrument remains attached to the bone, if desired. In addition to, or instead of, using jaws of the instrument, the instrument may be coupled to the bone with one or more wire members. (thus, the jaws may be omitted from the design of the instrument.) the system and method may mount or be configured to mount the cannula along the guide axis such that the cannula has an optimal position along the guide axis. For example, the cannula may have a shoulder that stops advancement of the cannula by contacting the distal cortex of the bone to set the position of the cannula along the guide axis. This configuration can place the distal end of the transverse orifice in close proximity to the distal cortex. The transverse aperture may be elongated (to form a slot) parallel to the long axis of the cannula so that when the cannula is installed in a bone, the transverse aperture substantially spans the medullary canal (in a direction across the canal). In some embodiments, the size of the transverse aperture may be selected by selecting the cannula from a set of cannulas having respective transverse apertures of different lengths (measured parallel to the long axis of the cannula). The width of the transverse aperture may be substantially maximized using a ramp, which may be formed in part by a protrusion on the collar, to further increase the reliability of the successful engagement of the staple with the collar.

Further aspects of the disclosure are described in the following sections: (I) an overview of the implant components of the fixation system, (II) anchors, (III) staples with offset tips, (IV) instruments, (V) drivers, (VI) methods of fixing bone, (VII) composition of the system components, and (VIII) examples.

I.Overview of implant components of fixation systems

This section provides an overview of exemplary implant components for the fixation system 50 of the present disclosure; see fig. 1-5.

Fig. 1 and 2 show a fixation assembly 52 of a fixation system implanted in a left fibula 54, the left fibula 54 having a fracture 56 in a diaphyseal region 58. The fixation assembly may include an intramedullary nail 60, the intramedullary nail 60 spanning at least one fracture 56 and extending through an anchor 62 for the nail. The anchor may encircle and lock to the nail and attach the nail to the bone. Nail 60 may be longitudinally disposed in a bone, and in particular, in medullary canal 64 thereof, with the long axes of the nail and bone generally aligned with each other (e.g., parallel and/or coincident). The anchors 62 may be implanted laterally into the bone (e.g., bi-cortical implants) and may cross the medullary canal. Alternatively, the anchor may be described as an implant, or in some embodiments, as an external fastener (i.e., external to the nail).

Staples 60 are elongated and may have a tail region 66 and a head region 68, each of tail region 66 and head region 68 may also be elongated. The tail region 66 and the head region 68 may be adjacent to each other or may be separated by a middle region of the staple. Regions 66, 68 may form opposite leading and trailing ends of the staple and may be integrally formed with one another. The leading region may have a smaller diameter (e.g., a smaller average diameter or maximum diameter) than the trailing region. Thus, the leading region may be described as the stem of the nail and the trailing region as the head. The anterior region may be configured to first enter the medullary canal when the nail is placed therein. The staples may be tapered or gradually reduced in diameter at one or more locations along their length. The anterior region 68 may include an elongate lockable portion that is uniform in diameter and sized according to the transverse aperture of the anchor. The anchor may be locked to the staple along the lockable portion over a continuous range of positions. The lockable portion may have any suitable length, such as at least about 5%, 10%, or 20% of the length of the staple.

To secure the fibula 54, staples may be attached to bone blocks 70, 72 (also described as bone segments) of the fibula 54 (or another bone) positioned on opposite sides of the fracture 56. The tail region 66 of the nail may define one or more lateral openings 74 (such as through or blind holes) to receive fasteners (such as threaded fasteners (e.g., screws)) that attach the tail region to the bone block 70 and/or the end region 76 of the bone. Each opening 74 may or may not include internal threads that are complementary to the external threads of the fastener. For narrow bones, such as fibulas, the anterior region 68 may be too thin to define any openings (such as holes) that receive fasteners without compromising the strength of the nail. The anchor 62 disclosed herein provides attachment of the anterior region 68 of the nail 60 to the bone block 72 and/or the diaphyseal region 58 to stabilize the fibula 54 and promote bony engagement (osteopynthesis) at the fracture.

The staples 60 may be linear or may have a preformed radial curvature, for example, as indicated at 78. Thus, the staple may define a long axis 80 that is linear or non-linear (straight or non-straight). The nail may also be sufficiently flexible, particularly in the anterior region 68, to deform when the nail is placed in the medullary canal of a bone such that the nail follows the longitudinal shape of the medullary canal.

The anchor may be elongated, but substantially shorter than the nail. For example, the staple may be at least five or ten times the length of the anchor and/or its cannula.

The anchor 62 may be introduced into the fibula 54 from one side of the fibula 54 in the diaphyseal region 58. The anchor may be placed in the bone along an axis transverse (such as substantially orthogonal) to the long axis of the bone. In the depicted embodiment, the anchor 62 is introduced from the anatomically lateral side of the fibula 54 and advanced along the medial-lateral axis of the bone, but in other embodiments the anchor 62 may be introduced from any suitable side of the fibula or other bone.

Fig. 3-5 show anchor 62 and its relationship to nail 60 and fibula 54 in greater detail. The anchor 62 may include an assembly of a sleeve 82 and a locking member 84, with the sleeve 82 and the locking member 84 being separate from and attached to one another. The sleeve may be interchangeably referred to as a housing. The sleeve 82 may define a cavity 86, and at least a portion of the lockable portion 88 of the staple 60 and at least a portion or all of the locking member 84 may be received in the cavity 86. The lockable portion 88 can be cooperatively gripped by the sleeve 82 and the locking member 84 to lock the staple to the sleeve/anchor (see fig. 5). For example, the sleeve 82 may define an internal thread 90 and the locking member 84 may be a set screw having a complementary external thread 92, or vice versa, to provide a threaded engagement between the sleeve and the locking member. (extensions of either thread may also result from material deformation during installation of the fixation system; see example 1.)

The locking member 84 can be rotated to adjust its axial position in the sleeve to advance the leading end 94 of the locking member so that the nail portion 88 is tightly gripped on its opposite sides by the leading end 94 and the inner wall region 96 of the sleeve 82 to lock the nail to the anchor. The inner wall region may be complementary (e.g., cylindrical in shape) to the spike. The locking member may be configured to be positioned completely inside the sleeve 82 when the staple is locked to the sleeve, with the trailing end of the locking member flush or recessed relative to the sleeve.

The leading end 94 of the locking member 84 and/or the inner wall region 96 of the sleeve 82 may be configured to further inhibit sliding of the locked staple. One or both may have protruding features, which in some embodiments may be configured to dent the surface of the nail 60 when the nail is tightly clamped. For example, the front end 94 may form a distally projecting rim or spike (spike) that may be centered on the long axis of the locking member (see example 1 of parts II and VIII), and/or the inner wall region 96 may define one or more proximally projecting ridges, bumps, spikes, or the like to contact the staple. To facilitate deformation of the staple by the protruding features, the staple may be formed of a softer material than the sleeve 82 and/or the locking member 84. In an exemplary embodiment, the nail may be formed of titanium or a titanium alloy, and the sleeve and/or the locking member may be formed of cobalt-chromium alloy (interchangeably referred to as cobalt-chromium alloy) or the like.

The cannula 82 may have a tail portion 98 and a nose portion 100 arranged coaxially with one another, with each portion centered on a long axis 102 of the cannula (see fig. 4). The tail portion 98 may extend to the trailing end 104 of the cannula and the leading portion 100 may extend to the leading end 105 of the cannula. The sleeve may be unitary (one piece only) and/or may be configured to be installed as a unit. The tail portion 98 and the nose portion 100 may be integrally formed with one another. In other embodiments, the tail portion and the nose portion may be formed separately from one another and then rigidly attached to one another. The tail portion and the nose portion may be adjacent to each other.

The tail portion 98 may be substantially wider than the front portion 100 such that these portions form a body 106 and a post 108. For example, the tail portion may have a diameter (e.g., average diameter) that is greater than a diameter (e.g., average diameter) of the front portion. In some embodiments, the average diameter of the tail portion may be at least about 1.5 times, 2 times, 2.5 times, or 3 times the average diameter of the head portion. Each portion may be substantially cylindrical, as shown in the depicted embodiment. The post may stabilize the sleeve against wobbling within the bone.

The tail portion 98 may form a shoulder 110 at its distal end (see fig. 4 and 5). The shoulder may be formed by an abrupt termination of the body 106, as in the depicted embodiment, or by a more gradual linear or non-linear reduction in the diameter of the body 106, as indicated by the dashed line at 112 in fig. 4. Thus, the shoulder may be planar and may lie in a plane oriented orthogonally to the long axis 102, may be conical, or may be circularly contoured (e.g., spherical), etc. (see also example 1 of section VIII). The shoulder may form an angle (e.g., a maximum angle or an average angle) of at least about 50 degrees, 60 degrees, 70 degrees, or 80 degrees with the long axis 102 (and/or the post 108) such that the shoulder is configured to act as a stop during installation of the cannula.

The tail portion 98 and the nose portion 100 may have different lengths from one another, with the lengths measured parallel to the long axis 102. The different lengths may correspond to different locations and functions of each portion within the bone, as illustrated by the cutaway fibula 54 in fig. 4. The cortex 116 of fibula 54 forms a dense, solid shell around medullary canal 64 in which nail 60 is positioned. The laterally spaced regions of the cortex 116 that are closer and farther, respectively, from the entry site of the cannula 82 are depicted as the near cortex 118 (near the site) and the far cortex 120 (far from the site). The tail portion 98 may be only partially positioned in the near cortex 118 and may cross the medullary canal 64. The shoulder 110 may be configured to contact the distal cortex 120 to prevent advancement of the cannula into the bone during installation of the cannula. The trailing end of the tail portion may be recessed, flush, or protruding relative to the exterior of the bone. The anterior portion 100 of the cannula may extend into the distal cortex 120 and/or through the distal cortex 120, and may be positioned at least primarily in the distal cortex 120, or at least primarily in the distal cortex and/or outside of the bone, as in the depicted embodiment where the rounded end of the anterior portion 100 protrudes from the distal cortex. In other embodiments, the tip may be pointed or blunt, etc.

The cannula 82 may be configured to attach to the near cortex 118, the far cortex 120, or both. The caudal portion 98 and/or the anterior portion 100 may have at least one radial projection configured to attach the portions to bone by engaging (such as threadingly engaging) a corresponding region of the cortex. Each radial protrusion may, for example, include or form at least one thread, tooth, fin, barb, annular ridge, axial ridge, and/or the like. In some embodiments, one or both portions 98, 100 may have one or more radial protrusions forming an external thread structure, which is any fastening structure corresponding to at least one continuous or segmented external thread. In the depicted embodiment, the external thread formation 121 with segmented external threads is created by radial projections 122 formed only on the tail portion 98, with each radial projection defining a plurality of teeth 124, as described in more detail in section II. In other embodiments, the external thread structure 121 having a more continuous configuration may result from one or more helical protrusions on the body 106 (see example 1 of section VIII), and/or a continuous/segmented external thread structure may be formed on the post 108.

The fibula is merely exemplary. Other suitable bones that may be fixed with the fixation systems disclosed herein may include long bones, particularly long bones with narrow axial regions, such as the ulna, but the fixation assembly may be used with any suitable bone (e.g., radius, humerus, femur, tibia, clavicle, etc.). In the depicted embodiment, the nail 60 enters the fibula 54 from the anatomical distal end of the bone, and then the anterior region 68 is attached to the anatomical proximal bone piece 72. However, in other embodiments, the nail may be introduced into the bone from an anatomically proximal end of the bone, and the anterior region 68 may be attached to an anatomically distal mass of the bone.

The terms "proximal" and "distal" have different meanings herein for implants and bone. The terms "proximal" and "distal" as used to describe an implant or instrument mean closer to and further from a site of entry into a bone and/or a surgeon, respectively, during installation or use, and generally correspond to "caudal" and "anterior", respectively. The terms "proximal" and "distal" as used to describe regions along a long bone mean closer to and further from, respectively, a site attached to the torso.

II.Anchoring member

This section describes additional aspects of an exemplary anchor 62 for use in the fixation system of the present disclosure, as well as an exemplary coaxial cortical borehole into which the anchor may be installed; see fig. 6-16.

Fig. 6-10 show various views of the cannula 82 described in section I above. As already discussed, the cannula may have a proximal cylindrical body 106 and a distal post 108, the distal post 108 may or may not be cylindrical and/or axially elongated. Further, the sleeve may have a plurality of outer radial projections 122 formed on the body 106 and arranged to provide an external threaded configuration or otherwise restrict removal of the sleeve from the bone.

Body 106 may be hollow, defining a cavity 86, to allow the body to radially receive spike 60 and axially receive locking member 84 (see also fig. 3-5). More specifically, the cavity 86 may include a transverse aperture 126 that intersects an axial opening 128. The transverse aperture is a through aperture that extends transversely through the body (e.g., orthogonal to the long axis 102, such as radially through the body as a radial aperture). The transverse aperture may be formed in part by the inner wall region 96. The transverse aperture 126 may be sized to allow the nail 60 to be progressively and longitudinally advanced through the body from its leading end until the lockable portion of the forward region of the nail is partially positioned in the transverse aperture and extends through the cannula 82 (e.g., radially). The transverse aperture may be a slot elongated parallel to the long axis 102 to increase the size of the aperture, thereby increasing the chance of the leading end of the staple successfully entering the cannula. The axial opening 128 may be sized to receive the locking member 84 and may define the internal threads 90.

The transverse aperture 126 may taper inwardly at one or both ends to form at least one inlet 130. The entry further increases the target size of the orifice, thereby increasing the chance of the leading end of the nail successfully entering the body of the cannula. In the depicted embodiment, a pair of inlets 130 are defined by opposing lateral sides of the body 106. Each inlet 130 may be formed as a chamfer 132, which may be a circumferential chamfer as shown. At least a portion of at least one or each inlet/ramp may be formed by a radial projection (e.g. projection 122) on the body 106. The chamfer may define any suitable acute angle with the through axis 134 of the aperture 126, such as an angle greater than about 35 degrees, 40 degrees, or 45 degrees, etc. The increase in the target size of the transverse orifice created by the chamfer is shown in fig. 9 and 10. The chamfer may increase the maximum width 136 of the aperture (i.e., the width of the inlet; as compared to the interior width 138) and/or may increase the maximum length 140 of the aperture (i.e., the length of the inlet; as compared to the interior length 142). In some embodiments, the inner width 138 may be at least about half of the average diameter of the body 106 (ignoring any protrusions formed on the body 106). In some embodiments, the width 136 of the inlet 130 may be at least about 40% or 50% greater than the interior width 138, and/or may be at least about 75%, 80%, or 90% of the average diameter of the body 106 (as defined above). In some embodiments, the interior length 142 of the aperture 126 and/or the length 140 of the or each inlet 130, 130 may be greater than half the length of the body 106 measured parallel to the long axis 102.

The radial projections 122 may be described as wings (see fig. 8). The protrusions may be circumferentially spaced from each other on the body, and may be evenly spaced. For example, the depicted embodiment has four protrusions 122 spaced 90 degrees apart from each other to define an X-shape in an end view of the cannula. In other embodiments, the sleeve may have a different number of protrusions 122, such as 2, 3, 5, or 6, among others. Each protrusion may be linear and arranged axially on the body 106 parallel to the long axis 102, may be helical, or may have some other arrangement.

The body 106 may have teeth 124 formed laterally on the body 106, optionally provided by protrusions 122 (see fig. 7). The teeth may be arranged in spaced columns 144, each extending parallel to the long axis 102, and the columns may be evenly spaced from each other, as described above for the projections 122. The co-considered teeth may be arranged on the same helical path 146. The pitch (p) of the helical path (i.e. the distance between successive complete turns of the path) may be equal to the centre-to-centre spacing of adjacent teeth within each column. The rows of teeth may be axially offset from each other by a fraction of the pitch to place some or all of the teeth on a helical path. For example, for n evenly spaced rows of teeth, the rows may be successively offset from each other by a distance of p/n. The axial row of teeth allows the sleeve to be driven into the bone continuously, either axially/translationally (without substantial rotation) or by rotating the sleeve (such that the teeth act as external threads), or both. In other embodiments, the teeth may be replaced by more complete external threads (see, e.g., example 1 of section VIII).

The cannula 82 may have a driver engagement structure formed internally, externally, and/or at its proximal (trailing) end to facilitate driving the cannula translationally and/or rotationally into the bone. In the depicted implementation, the body 106 defines a pair of recesses 148 at a trailing end thereof. The recesses may be diametrically spaced from each other. The corresponding driver is described in section V below.

Fig. 11-13 show various views of the locking member 84 described in section I above. The locking member may have a cylindrical shaft 150 with external threads 92 formed thereon. The length of the locking member, measured parallel to the long axis 152 of the locking member, may be less than the length of the body 106 of the cannula 82, such as approximately equal to the length of the body 106 minus the diameter of the portion of the staple extending through the body, and also minus the distance between the distal end of the body 106 and the inner wall region 96 of the body that engages the staple. With this length, the proximal end of the locking member may be flush or recessed relative to the proximal end of the cannula when the locking member is operably engaged with the staple.

The proximal end of the locking member 84 may define a driver engagement structure 154. In the depicted embodiment, the structure 154 is a hexalobular recess, but any suitable internal and/or external driver engagement structure may be present.

The distal end of the locking member 84 may define a protrusion 156, the protrusion 156 configured to engage and optionally deform the staple. In the depicted embodiment, the protrusion 156 surrounds the central recess 158 such that the distal end of the locking member forms an annular ledge to engage the staples.

Fig. 14 shows a set of sleeves 82 and corresponding locking members 84 that may be included in the fixation system 50. The set of sleeves and locking members allows the surgeon to select the appropriate size of anchor for a given bone and particularly for the particular region of the bone in which the anchor is to be installed. The sleeves have the same diameter but different lengths from each other. The difference in length may be determined by the body 106 of each sleeve. In other words, the bodies 106 may be different lengths from one another, and the posts 108 may have the same length (and/or diameter) as one another. In the depicted embodiment, the posts 108 are identical to one another. The transverse apertures 126 may differ in length in the sleeve 82 measured parallel to the long axis 102, which is directly related to the different lengths of the sleeve 82 and/or the body 106 of the sleeve 82. By increasing the length of the aperture 126 (and thus the portal 130), the target area for the nail to enter the cannula is increased for locally larger diameter bones. The elongated portal 130 may substantially span the medullary canal of the bone, which simplifies alignment of the leading end of the nail with the portal.

The locking member 84 may vary in length consistent with different lengths of the body 106. Each locking member 84 may have the following length: i.e., approximately the length of the corresponding body 106 minus the diameter of the staple extending through the front region of the body, and also minus the distance between the distal end of the body 106 and the inner wall region 96 of the body that engages the staple.

Figures 15 and 16 show the fibula 54 ready to receive the sleeve 82 and fitted with the sleeve, respectively. In figure 15, the medullary canal 64 has been reamed, if necessary, and the fibula 54 has been double-skinned to form a pair of coaxial cylindrical holes, a wider hole 160 through the proximal cortex 118 and a narrower hole 161 in the distal cortex 120 and optionally through the distal cortex 120. In fig. 16, body 106 has been placed in wider bore 160 and medullary canal 64, and post 108 has been placed in narrower bore 161 and protrudes from fibula 54. The shoulder 110 abuts the distal cortex 120 and is optionally positioned in a matching/complementary recess formed in the inner side of the distal cortex adjacent the narrower aperture 161. The length 140 of portal 130 is greater than the local width of medullary canal 64.

III.Nail with offset tip

This section describes an exemplary offset tip 162 for a staple 60 of a fixation system 50, and a process for utilizing the tip 162 to help correct misalignment and guide the staple into the cannula 82; see fig. 17-20. The offset tip may be interchangeably referred to as a kick tip.

Fig. 17-20 illustrate a series of exemplary positional relationships of the staple 60 and the sleeve 82 relative to one another. These positional relationships may be generated after the cannula has been transversely installed in the bone and when the staples are mated to the cannula by the surgeon. In other words, cannulation 82 is stationary and nail 60 is advanced longitudinally along the medullary canal of the bone, as indicated by the motion arrows at 164, 166, and 168, to place a portion of anterior region 68 of the nail within transverse bore 126 of the cannulation. The spike 60 and the cannula 82 are viewed parallel to the long axis 102 of the cannula with the cannula 82 sectioned orthogonally to the long axis as in fig. 9 so that the tip 162 of the spike remains visible as it enters and passes through the transverse aperture 126.

In some embodiments, the surgeon may fluoroscopically (fluoroscopically) monitor the positional relationship of the staple 60 and the cannula 82 when the staple is mated with the cannula in generally the manner shown, with the viewing axis parallel to the long axis 102. The portal 130 of the transverse bore 126 may at least substantially span the medullary canal parallel to the long axis 102 by selecting an appropriately sized anchor/cannula from a group, as explained in section II above. Thus, the surgeon can generally successfully perform the mating procedure illustrated in fig. 17-20 without the need to fluoroscopically view the cannula and staple along a viewing axis that is orthogonal to the long axis 102 (e.g., parallel to the transverse axis 170).

Fig. 17 shows only a distal portion of the forward region 68 of the staple 60. The front region 68 has an elongate main portion 171 and a tip 162 positioned distally thereof. The tip may be elongated to define a tip axis 172, the tip axis 172 not being collinear with a long axis 173 defined by the main portion 171. The axes 172, 173 may be substantially parallel to each other or may be substantially non-parallel to each other. In the depicted embodiment, the axes are spaced from each other by a radial offset 174 created by a curved region 176 (e.g., double bend) in the nail. When the staples extend longitudinally through the bending zone, the staples may bend radially in respective opposite directions. Each bend may be in the plane of bending of tail region 66 of staple 60. As shown, the tip may be tapered or cylindrical and may have a rounded or pointed distal end.

Misalignment of the staple 60 and the cannula 82 relative to each other can prevent the distal end of the staple from entering the entrance 130 of the transverse aperture 126 (see fig. 17). For example, in the depicted configuration, the distal end of tip 162 is in contact with lateral protrusion 122 and cannot advance, as indicated by the scribed motion arrow at 178.

Fig. 18 shows the position of the nail 60 after it has been rotated by the surgeon half a turn around its long axis, indicated by the rotational arrow at 180. The tip axis 172 now intersects the entrance 130 of the aperture 126 and the ramp 132 of the entrance provides a ramp that helps the tip 162 to be laterally centered in the aperture 126 as the staple is advanced at 164. In other embodiments, the staples may be rotated by different amounts, such as 90 degrees or the like.

Fig. 19 shows the tip 162 being advanced, indicated by motion arrow 166, further into the transverse aperture 126. The tip is further centered by contact between its tapered wall and the interior region of the transverse aperture.

Fig. 20 shows further advancement of the tip indicated by motion arrow 168 after the tip and bending region 176 has passed through the cannula 82. If desired, the staple may be counter-rotated about axis 80 for a half turn, indicated by the rotational arrow at 182, to return the staple to its original rotational orientation. In the depicted embodiment, nail 60 has a pre-formed radial curvature 78 (see FIG. 1), which may preferably follow the radial curvature of the medullary canal. The radial curvature 78 and the offset of the tip 162 may be in the same plane.

IV.Instrument and method for operating the same

This section describes exemplary embodiments of non-implantable instruments of the fixation system 50 to facilitate installation of the cannula 82 and/or the locking member 84 (see sections I and II), and procedures for using the instruments; see fig. 21-38.

Fig. 21 shows an embodiment 190 of the instrument having a clamp portion 192 coupled to a guide portion 194. A pair of opposing clamping jaws 196 of the clamp portion may be engaged with the fibula 54 such that the fibula is clamped between the clamping jaws, and/or one or more wire members 198 may be placed through one or more wire receiving channels 200 defined by the instrument to couple the instrument to the bone. Coupling the instrument to the bone with the clamping jaw 196 and the at least one wire member 198 may provide greater stability of the instrument on the bone. The guide portion 194 defines a guide axis 202. At least one drill 204 may drill the fibula 54 (or another bone) on the guide axis to prepare the fibula to receive the sleeve 82, and/or the sleeve may pass through the guide portion 194 along the guide axis 202 and into the fibula. (Each drill may be interchangeably referred to as a drill bit.)

At least one drill may drill holes in the fibula 54 (or another bone) in a bi-cortical fashion to form wider holes in the near cortex and narrower holes in the far cortex, as described in section II above (see, e.g., fig. 15 and 16). In some embodiments, respective corresponding drills may be used to form different sized holes. Alternatively, the step drill 204 may be used to form two holes in a single pass. The stepped drill may have a shaft 206 with a proximal bore portion 208 to form a wider bore, and a nose protrusion (nose)210, the nose protrusion 210 protruding from the shaft and providing a distal bore portion 212 to form a narrower bore. In some embodiments, the proximal and distal drilling portions of the drill may be configured to preferentially drill in opposite rotational directions of the drill from each other, as described in U.S. patent application serial No. 15/728,247 filed on 2017, 10, 9, incorporated herein by reference. (the terms drilling, and forming holes are used interchangeably herein.) the shaft 206 may be sized to extend through a guide channel 214 defined by the guide portion 194 and centered on the guide axis 202.

Instrument 190 can include a coupling assembly 216 that couples clamp portion 192 and guide portion 194 to one another. The coupling assembly holds the guide portion centered, as explained in more detail below, and may include a retainer 218 (interchangeably referred to as a housing) for the guide portion and a pair of link members 220.

Fig. 22 and 23 show instrument 190 without guide portion 194, and with clamping jaw 196 in the closed and open configurations, respectively. The instrument may have a pair of levers 222a, 222b, the levers 222a, 222b being pivotally connected to each other at a fulcrum 224 defining a pivot axis 226 (see also fig. 21). The jaw 196 is formed by a portion of the lever positioned distal of the fulcrum 224, and a pair of handle members 228 may be formed by the lever proximal of the fulcrum.

Coupling assembly 216 holds retainer 218 in a fixed position relative to central plane 230 as the distance between jaws 196 changes (i.e., as the jaws open (move farther apart) or close (move closer together)) (compare fig. 22 and 23). The central plane may contain the pivot axis 226 and may remain equidistant from the jaws (and optionally the handle members 228) as the spacing of the jaws (and optionally the handle members 228) changes. The guide portion 194 and in particular the guide axis 202 thereof may thus remain located in the central plane 230 when the jaws are opened and closed. This positional relationship ensures that the guide axis extends across the bone, near the long axis of the bone, when the jaws engage the opposite side of the bone. In some embodiments, the guide axis may be adjustably offset from the central plane, if desired, as described below.

Fig. 24 and 25 show various partial views of instrument 190 in the configuration of fig. 22 and 23, and illustrate how coupling assembly 216 may operate. The holder 218 may be pivotally connected to the levers 222a, 222b on a pivot axis 226. The link members 220 may be pivotably connected to each other and to the holder 218 at one end of each link member to form a pivotable connection 232, and may be pivotably connected to a respective lever 222a or 222b at the other end of each link member, as indicated at 234. Retainer 218 may define a slot 236 that allows pivotable connection 232 to slide along as the jaw spacing changes (compare fig. 24 and 25). As a result, angular movement of the lever relative to the retainer 218 is coupled and the retainer 218 cannot pivot out of alignment with the central plane 230. In some embodiments, the positions of fulcrum 224 and slot 236 may be switched. In other embodiments, the same type of centering action may be created by replacing the slot 236 with a circular aperture and providing a slot in each lever 222a, 222b so that each pivotable connection 234 may slide along the corresponding lever as the jaws open and close.

Fig. 22 and 23 illustrate additional exemplary aspects of the instrument 190. The instrument may have a locking mechanism 238 to prevent the jaws from being opened (moved further). The locking mechanism may or may not restrict the jaws from closing (moving closer) as this action may be exerted by the bone engaged by the jaws on opposite sides. In the depicted embodiment, the instrument 190 has an externally threaded member 240, the externally threaded member 240 being pivotally connected at one end to the lever 222b, extending through a collar 242 of the other lever, and being threadedly engaged with an internally threaded wheel 244. In fig. 22, the locking mechanism is in the unlocked configuration because the wheels 244 are spaced from the collar 242, and in fig. 23, the locking mechanism is in the locked configuration in which the wheels are in contact with the collar. In other embodiments, the locking mechanism may include meshing teeth or the like.

The instrument 190 may also have a gauge 246 to measure the spacing of the jaws from one another and, thus, the local width of the bone engaged by the jaws. The gauge may be positioned proximally or distally relative to the fulcrum 224. In the depicted embodiment, the gauge is associated with the handle member 228. Specifically, the gauge has a scale 248 attached to one of the handle members 228, and a pointer 250 attached to the other handle member. The scale 248 may be arcuate or linear, etc.

Fig. 22A shows a further aspect of a scale 248. The scale may include markings 252 to indicate the current spacing of the jaws from each other. The indicia may include graduation symbols (which may be evenly spaced), alphanumeric characters (e.g., numbers), color coding, and the like. For example, the numbers may report the distance between the jaws (e.g., in millimeters). The color coding may indicate whether the jaw spacing (and thus the local bone width) is sufficient for safe introduction of the anchor. In the depicted embodiment, the portions 253a, 253b and 253c of increasing distance along the graduated scale distance lever 222a are colored red, yellow and green, respectively, to indicate high, medium and low risk of drilling and/or insertion of the anchor.

Fig. 26 and 27 illustrate exemplary positional relationships between the wire member 198, the instrument 190, the fibula 54, and the medullary canal 64. The jaws 196 may define teeth 254 to engage opposite sides of the bone and improve grip (purchase). When the jaws are fully closed and for a range of open positions of the jaws, the jaws may be angled distally inward toward the central plane 230 to prevent removal of the locking instrument from the bone. The jaws engage the bone in a clamping plane 256, which clamping plane 256 may be oriented at least generally orthogonal to a long axis 258 of the bone when the instrument is properly clamped to the bone (see fig. 21). The clamping plane may be at least substantially parallel to the guide axis 202, and optionally spaced from the guide axis 202, and orthogonal to the central plane 230. Each of the jaws may be oriented at an oblique angle relative to a plane orthogonal to pivot axis 226 (at least substantially orthogonal (or parallel) meaning within 10 degrees of exactly orthogonal (or parallel)). Thus, when the jaws are opened or closed, the jaws may travel along the surface of the cone centered on the pivot axis 226.

The channel 200 of the instrument may define a track of wire members 198 that extend transversely into and/or transversely through the bone. The channel may be defined by the retainer 218, one or both levers 222a, 222b, or both the retainer and one or both levers. The trajectory may be configured to extend through at least a region of the bone spaced along the bone from the clamping plane 256 and the guide axis 202. For example, in the depicted embodiment, guide axis 202 is positioned intermediate clamping plane 256 and the region of the fibula that receives wire member 198. In other embodiments, the clamping plane 256 may be positioned along the fibula between the area of the fibula that receives the wire member 198 and the guide axis 202. In still other embodiments, a pair of trajectories may pass through the bone on opposite sides of the clamping plane from each other.

The wire-receiving channel may be configured to define a trajectory through the cortical bone while avoiding at least a radially central portion of the medullary canal to allow the leading end of the nail to be advanced along the medullary canal past the wire member. In other words, the wire member avoids the space occupied by the staples. Each trajectory may pass through the central plane 230 before or after the trajectory has passed through the bone. For example, in fig. 26 and 27, two wire members pass through the central plane 230 before reaching the bone, while in fig. 28, the wire members pass through the bone before reaching the central plane 230.

After the nail has been temporarily positioned in the medullary canal (generally in the space that the nail will occupy after locking of the nail to the sleeve), each wire member may be placed in/through the bone. Placing the nail in this position ensures that after the nail has been retracted to allow drilling and installation of the sleeve along the guide axis, the wire member, when placed into the bone, will not hinder re-advancement of the nail into the space.

Fig. 29 shows a pair of schematic fluoroscopic images illustrating adjustment of the position of the guide portion 194 of the instrument 190 when the instrument is clamped to the fibula 54 and further stabilized with a wire member (not shown), indicated by the arrow at 260. The guide portion and the nail 60 (or reamer) are viewed generally coincident with the guide axis 202 and may be (at least partially) radiopaque so that they are readily visible under fluoroscopy. The leading end of the nail has been advanced along the medullary canal of the fibula 54 past the guide axis 202 and over the guide portion 194.

In the left image, the guide channel 214 of the guide portion 194 is not centered on the long axis of the nail 60 (or reamer). Thus, if there is no improvement in the alignment of the guide portion 194 and the nail 60 prior to drilling the fibula on the guide axis 202, it may be difficult for the surgeon to feed the nail through the sleeve 82 installed in the drilled fibula. As described in more detail below, while the instrument remains clamped to the bone, the position of the guide portion 194 may be adjusted to improve alignment of the guide portion with the nail, as shown in the right image.

Fig. 30A-30C, 31 and 32 illustrate an exemplary adjustment mechanism of instrument 190 for changing the position of guide portion 194 relative to retainer 218 (and central plane 230). This adjustment moves guide portion 194 while retainer 218 and the jaws of the clamp portion remain stationary. This adjustment may allow the guide axis 202 to be offset in opposite directions relative to the central plane 230 (see also fig. 22 and 23), optionally by the same distance, to improve alignment of the guide axis with the long axis of the nail. As described below, the guide portion may be locked in place by using complementary mating structures provided by the guide portion and the retainer 218. The complementary mating structures may mate with one another in a variety of alternative configurations to provide a plurality of predetermined, discrete adjustments to the offset of the guide axis relative to the central plane 230. In other embodiments, the adjustment mechanism may allow the spacing of the guide axis from the central plane to be adjusted over a continuous range of positions.

The guide portion 194 may include a tube 262 defining the guide channel 214. A cap 264 (also referred to as a button) may be securely attached to the proximal end of the tube 262 (see fig. 30A and 32), such as with a plurality of set screws. The guide channel 214 may be open only at both ends, or may also be open laterally along at least a portion of its length to form a trough (furrow) 266. A locking sleeve 268 may encircle a portion of the tube 262. The locking sleeve may be proximally formed with a knob 270, which knob 270 may be knurled. The axial tangs 272 may be distally bounded by the locking sleeve (see fig. 32). The distal portion 274 of the tang may be received in an axial groove 276 defined on the radially outer side of the tube 262 to prevent rotation of the tube and locking member relative to each other about their coincident long axes 278 (see fig. 31 and 32). The proximal portion 280 of the tang may be received in and may be complementary to each of a plurality of pockets (pockets) 282a, 282b, 282c, the pockets 282a, 282b, 282c being defined by an opening 284 through the retainer 218. Tube 262 is retained in opening 284 of the retainer by retainer (retainer)286, retainer 286 preventing any axial movement of the tube while allowing the tube to rotate about its long axis when unlocked by locking sleeve 268. The locking sleeve may be urged distally parallel to the guide axis 202 by a spring 288 to keep the guide portion locked.

Fig. 30A-30C illustrate exemplary adjustment of the rotational position of the guide portion 194. In fig. 30A, the proximal portion 280 of the tang 272 is positioned in the central well 282b, thereby locking the tube 262 in place. In fig. 30B, the guide portion has been unlocked by pushing locking sleeve 268 proximally relative to tube 262 parallel to long axis 278, as indicated by the motion arrow at 290. Upward pressure may be applied to the knob 270 to compress the spring 288 and remove the proximal portion 280 of the tang 272 from the pocket 282 b. In fig. 30C, the guide portion 194 has been rotated, as indicated by the rotational arrow at 292, to align the tang 272 with the pocket 282a while the spring 288 remains compressed. The tang 272 may then be allowed to enter the recess 282a by releasing the upward pressure on the knob 270, thereby re-locking the guide at a new rotational position.

Fig. 31 shows a cross-sectional view of the guide portion in the locked position of fig. 30A. The position of the guide channel 214 in the alternative locking position of the guide tube is shown in dashed lines.

Fig. 33A-33C, 34 and 35 show only the guide portion 194 and the retainer 218 of another exemplary embodiment of an installation instrument 190' for the fixation system 50. The instrument 190' may have any suitable combination of the elements and features described above for the instrument 190, such as a clamp portion and its coupling assembly. Accordingly, functionally similar components of the instruments 190 and 190' have been assigned the same reference numerals.

The guide portion 194 of the instrument 190' has a tube 262 defining a guide axis 202. The position of the guide axis can be changed by moving the tube relative to the retainer 218 to a different alternative mating configuration of the tang 272 with one of the plurality of pockets 282a-282c defined by the retainer 218. However, in contrast to instrument 190, tube 262 of instrument 190' is axially and rotationally movable relative to holder 218, as further described below.

The tube 262 has a tubular body 300 defining the channel 214 and projections, i.e., tangs 272 and tabs 302, extending laterally therefrom (see fig. 33A-33C and 35). One or both of the tang 272 and the tab 302 may be integrally formed with the body 300. The threaded member 304 may be attached to the protrusion 302 at an internally threaded through-hole 306 defined by the protrusion. More specifically, the threaded member may have a graspable head 308 forming a knob, the graspable head 308 being coaxial with the shaft 310 and rigidly attached to the shaft 310 (see fig. 35). The head may be knurled. The shaft may have external threads near the head for threaded engagement with the through bore 306. The shaft 310 may define a pair of circumferential recesses 312, 314, the pair of circumferential recesses 312, 314 configured to receive lateral portions of a locking pin 316, respectively, to retain the tube 262 in the locked or unlocked configuration. The shaft may be received in an axial bore (bore)318 defined by the retainer 218.

The locking pin 316 may extend into a transverse bore 320 defined by the retainer 218 (see fig. 34). The pin may have a shaft 322 defining a waist 324, and a button 326 may be formed at a proximal end of the shaft. The spring 328 may bias the position of the shaft 322 such that the waist 324 is not aligned with the shaft 310 of the threaded member 304 until the user applies pressure to the button 326 to compress the spring 328.

Fig. 33A-33C illustrate adjustment of the position of the tube 262 to change the spacing of the guide axis 202 from the central plane 230 of the holder 218 (see also fig. 34). In fig. 33A, the guide axis 202 is contained by the central plane 230 and the tube 262 is locked in its central position. More specifically, tang 272 is positioned in central well 282b of retainer 218. Axial movement of the tube 262 is prevented by a locking pin 316, which locking pin 316 is partially positioned in the upper recess 312 of the shaft 310 of the threaded member 304 (see also fig. 35).

In fig. 33B, the button 326 of the locking pin 316 has been pressed, indicated by the motion arrow at 330. The locking pin moves inwardly parallel to its axis, which moves the waist 324 of the locking pin into alignment with the shaft 310 of the threaded member 304 (see also fig. 34). The tube 262 is now unlocked and can be moved axially, as indicated by the motion arrow at 332, to remove the tang 272 from the central well 282 b. The tube may be axially locked in the retracted position shown in fig. 33B, with the locking pin 316 partially positioned in the lower recess 314.

In fig. 33C, the unlocked tube 262 has been moved laterally and reoriented, as indicated by the rotational arrow at 334, by pivoting the tube about an axis 336 defined by the shaft 310 of the threaded member 304. The tang 272 has been aligned with the lateral recess 282 c. The tube can then be moved axially to place the tangs in the lateral pockets until the locking pin 316 springs out to its locked position. The threaded member may be rotated via the head 308 to more securely fix the tube in place.

Fig. 34 shows the opening 284 of the retainer 218. The opening may be shaped to allow lateral movement of the tubular body of the tube 262 as the tube 262 pivots about the shaft 310 of the threaded member 304, as indicated by the movement arrow at 338.

Fig. 36-38 illustrate only the guide portion 194 and retainer 218 of another exemplary embodiment of an installation instrument 190 "for the fixation system 50. The instrument 190 "may have any suitable combination of the elements and features described above for the instrument 190, such as a clamp portion and its coupling assembly. Accordingly, functionally similar components of the instruments 190 and 190 "have been assigned the same reference numerals.

Holder 218 of instrument 190 "is substantially similar to holder of instrument 190. For example, the holder has a housing portion 350, the housing portion 350 defining the opening 284 to receive the tube 262. The retainer also has an arm 352, the arm 352 projecting from and in fixed relation to the housing portion and defining the slot 236. However, in comparison to instrument 190, slot 236 of arm 352 in instrument 190 "is positioned closer to housing portion 350 than bore 354, which is centered about pivot axis 226.

The tube 262 has a mating portion 356, the mating portion 356 defining a pair of ridges 358 formed on opposite sides of the mating portion. The ridges are parallel to the guide axis 202 defined by the tube 262. The ridges 358 are configured to be alternatively received in each of a plurality of pairs of grooves 360 defined by the housing portion 350 in the opening 284. Each pair of aligned recesses 360 defines a plane parallel to the central plane 230 of the instrument 190 "and orthogonal to the clamping plane 256. Thus, when the ridges 358 are mated with any aligned pair of grooves 360, the guide axis is either contained within the central plane 230 or parallel to and offset from the central plane 230 by movement of the tube 262 and holder 218 relative to each other parallel to the guide axis 202. In the depicted embodiment, the tube 262 may be held by the retainer 218 in five different positions within a plane orthogonal to the guide axis, indicated generally by the arrow at 362 in fig. 38. In other embodiments, more or fewer grooves may be provided to provide more or fewer positions for the guide axis. To change the position of the tube 262, the tube may be removed from the housing portion 350 and then re-mated at a desired location along the transverse axis 364. The tube may have an enlarged head 365 that may be knurled to facilitate gripping of the tube 262.

The guide portion 194 of any of the instruments 190, 190', 190 "may include at least one tubular insert 366, the at least one tubular insert 366 configured to be removably received in the tube 262. The insert may define an axial bore 368 extending axially through the insert. The insert 366 and in particular the bore 368 may be sized to guide a narrower tool (such as a drill or guide wire, or the locking member 84) into the bone. The outer diameter of the insert 366 may correspond to the inner diameter of the tube 262 such that the insert fits tightly in the tube and remains parallel to the guide channel.

V.Driver

This section describes an exemplary driver 380 for the fixation system 50 that is attached to the cannula 82; see fig. 39-42.

The driver 380 can have a distal shaft portion 382 attached to a proximal graspable handle portion 384. The shaft portion may be at least partially formed by a sleeve 386, the sleeve 386 being proximally fixed to the handle portion. A pair of projections 388 may project from the distal end of the sleeve. The protruding portion may be complementary to a recess 148 defined by the proximal end of the cannula 82 and mate with the recess 148. The lever member 390 having a knob 392 at a trailing end of the lever member 390 may extend through a channel 394 bounded by the handle portion 384 and the sleeve 386 and may rotate about its long axis relative to the handle portion and the sleeve.

The distal portion of the rod member may have external threads 396, the external threads 396 being complementary to the internal threads 90 of the cannula 82 (see also fig. 5). The shaft member may be axially movable to extend and retract the distal end of the shaft member from the sleeve. The sleeve 82 may be locked to the driver 380 in a defined rotational position by mating the projection 388 with the recess 148 when the lever member 390 is slightly retracted and then advancing and rotating the lever member to create a threaded engagement between the external threads 396 and the internal threads 90. Alternatively, the rod member may have a fixed axial position and may be rotated to provide a threaded engagement with the sleeve 82 that pulls the sleeve into mating relationship with the projection 388.

The handle portion 384 may be shaped or marked to indicate to the surgeon the orientation of the through-axis 134 of the cannula 82. For example, the handle portion 384 may be elongated in a transverse cross-section as shown in fig. 42 in a direction orthogonal to a plane 398 collectively defined by the long axis 400 of the driver 380 and the projection 388.

VI.Method of fixing bone

This section describes an exemplary method of fixing bone with the system of the present disclosure. The method steps described in this section may be performed in any suitable order and combination, and may be implemented using any suitable combination of the system components of the present disclosure and/or supplemented by any other method steps of the present disclosure.

The bone to be fixed may be selected. The bone may be a long bone or any other suitable bone. Exemplary bones that may be suitable include a leg bone (e.g., a femur, tibia, or fibula), an arm bone (e.g., a humerus, radius, or ulna), and the like. The bone may have any suitable discontinuity, such as at least one fracture, incision, discontinuity, or the like. The discontinuity may divide the bone into two or more portions (interchangeably referred to as segments or fragments) that may be fixed relative to each other using the method.

Nails for fixing bones may be selected. The staples may have any suitable combination of properties and characteristics as disclosed herein. For example, the length, diameter, longitudinal shape, flexibility and/or taper (taper) of the staple may be selected based on the bone selected and/or the location of the discontinuity. The staple has a lockable portion configured to lock to the anchor. The lockable portion may be elongate such that the anchor may be locked to the staple at a range of successive positions along the lockable portion (optionally positions in the anterior region of the staple).

A sleeve and corresponding locking member for the nail may be selected. The sleeve and locking member may be selected from a group of sleeves and locking members of different lengths. The dimensions of the sleeve and locking member may be selected based on a measured local width of the bone, such as the local width indicated by a gauge of the instrument engaged with the bone (see below).

The bone may be prepared to receive the nail longitudinally in the medullary canal of the bone. Preparation of the bone may include forming an access opening (access opening) to the medullary canal from an end region of the bone. The access opening may be formed by any suitable technique, such as perforating and/or drilling the bone. The medullary canal may then be reamed via the access opening using at least one reamer advanced longitudinally in the medullary canal. The reamer may remove cortical bone to widen the medullary canal, particularly in the axial region of the medullary canal. In some embodiments, the step of selecting a nail may be performed after reaming the medullary canal when the size of the medullary canal has been established by reaming. In some embodiments, the step of reaming may be omitted.

An incision may be made through the soft tissue to access a selected area of bone. The location of the cut may be generally located where the anchor will attach the nail to the bone. The position may be chosen such that the cut covers the intended position of the lockable part of the nail inside the bone.

An instrument having a clamp portion may be engaged with the bone through the incision to attach the instrument to the bone. As described above in section IV, the instrument can have a guide portion coupled to the clamp portion and defining a self-centering guide axis. The jaws of the clamp portion may engage opposite sides of the bone and may be held against the bone using a locking mechanism that prevents the jaws from moving away from each other. The jaws may engage the bone in a plane, and the plane may be transverse (such as substantially orthogonal) to a local long axis of the bone where the jaws contact the bone. The step of engaging the bone with the clamp portion may be performed with the nail already positioned in the medullary canal to help visualize the desired installed position of the lockable portion of the nail with fluoroscopy and to ensure that the guide axis defined by the instrument will intersect the lockable portion. In some embodiments, the location at which the clamp portion engages the bone may be selected by measuring the distance from the end of the bone at which the access opening has been formed to estimate where the lockable portion of the nail will be located after the nail is inserted into the bone.

The local width of the bone can be measured between the jaws with the gauge of the instrument. The gauge may numerically indicate the local width, and/or may indicate a risk level associated with mounting the cannula on the current guide axis. The risk level may be indicated by a color coding of the gauge. If the risk is deemed unacceptable, the instrument may be moved to a different location on the bone where the gauge indicates that the local width is sufficient and/or the risk level is deemed acceptable.

One or more wire members, such as K-wires, may be used to stabilize the position of the instrument, such as its orientation. Each wire member may have a leading end that passes through a channel defined by the instrument and into and/or through the bone on a trajectory defined by the channel. The trajectory may avoid the medullary canal of the bone and may pass through the bone below or above the medullary canal. In some embodiments, the instrument may be stabilized using two wire members placed on non-parallel trajectories that are closest to each other before (e.g., inside the instrument), inside the bone, or after passing through the bone.

The position of the guide axis defined by the instrument may be compared to the position of a nail or reamer extending along the medullary canal of the bone. The position of the guide axis and the staple may be determined fluoroscopically using a viewing axis that is substantially coincident with the guide axis. A radiopaque region of the guide portion, such as a tube of the guide portion, may be viewed to determine the location of the guide axis (e.g., at the center of a radiolucent channel defined by the tube). The position of the guide axis may be adjusted in a plane orthogonal to the guide axis to move the guide axis closer to the long axis of the nail or reamer. The adjustment may be performed by rotating the guide portion relative to the clamp portion of the instrument and/or by adjusting the translational position of the guide portion, etc. This adjustment may improve the alignment of the tip of the nail with the guide axis.

A hole may be formed in the bone on the guide axis. The holes may include wider holes formed in the near cortex and narrower holes formed in and/or through the far cortex, wherein the holes are coaxial with each other. The bore may be formed by a guide portion with at least one drill extending therethrough. The at least one drill may be a stepped drill forming two holes. In some embodiments, the stepped drill may have a shaft forming a wider hole and a nose forming a narrower hole, and the shaft and nose may preferentially drill in respective opposite rotational directions of the drill. In some embodiments, the at least one drill may be a pair of drills sized to respectively form respective holes. Each drill may be cannulated and may be advanced over a guide wire that is driven from a guide portion of the instrument into the bone over a guide wire. In some embodiments, the smaller drill of the pair of drills may be a k-wire.

The cannula may be attached to a driver (see section V) and placed through the guide portion of the instrument and into a hole formed in the bone. The cannula may be driven into the bone with the driver until the shoulder of the cannula bottoms out against the far cortex of the bone. The cannula may be driven until seated by pushing or driving the cannula into the bone or by using a screw thread or screw-like structure of the cannula and rotationally advancing the cannula into the hole. In the seated configuration, the forward portion of the sleeve may be positioned in and/or extend through the narrower bore. The orientation of the cannula about its long axis may need to be adjusted so that the through axis of the transverse aperture of the cannula is aligned with the long axis of the bone, as indicated by the cannula and/or the driver (e.g., a handle portion thereof).

The staple may be advanced through the transverse aperture of the cannula. Fluoroscopy may be used to assess whether the tip of the staple is properly aligned with the cannula as the tip of the staple approaches the cannula. In some embodiments, the staples may be rotated about their longitudinal axes to improve alignment prior to insertion of the tips of the staples through the transverse apertures (see section III).

A locking member may be inserted into the sleeve to lock the staple to the sleeve. The locking member may be advanced through the guide portion of the instrument and into the cannula while the instrument remains attached to the bone. The inner bottom wall of the sleeve and/or the end of the locking member may have features (protrusions) that engage the spikes to increase the retention of the interface.

The staples may be locked to one or more other anchors mounted at spaced locations along the staples. In some cases, the use of more than one anchor may be suitable for securing more than two segments of bone resulting from a fracture.

VII.Composition of system components

The staples, sleeves, and locking members disclosed herein may have any suitable composition, each may be formed of any suitable biocompatible and/or bioabsorbable (bioabsorbable)) material(s) illustrative biocompatible materials that may be suitable include (1) metals (e.g., titanium or titanium alloys, cobalt chrome alloys, stainless steel, magnesium or magnesium alloys (e.g., alloys containing magnesium, calcium, and zinc), etc.), (2) polymers/plastics (e.g., Ultra High Molecular Weight Polyethylene (UHMWPE), polymethyl methacrylate (PMMA), Polytetrafluoroethylene (PTFE), Polyetheretherketone (PEEK), and/or PMMA/Polyhydroxyethylmethacrylate (PHEMA)), etc.), (3) bioabsorbable materials or polymers/plastics (e.g., polymers of α -hydroxycarboxylic acids (e.g., polylactic acids such as P LL A, PD LL A and/or PD L A)), polyglycolic acids, lactide/glycolide copolymers, etc.), polydioxanonenes, polycaprolactones, polytrimethylene carbonates, polyethylene oxides, polyhydroxybutyrate, poly (PHB-hydroxybutyrate, poly butyrate), etc.), poly (PHB-hydroxybutyrate, poly-acrylate, poly-co-hydroxybutyrate, poly-mer, and the like, or any other embodiments thereof, formed of a metal, a poly (e.g., a.

VIII.Examples of the invention

The following examples describe selected aspects and embodiments of the present disclosure in relation to the bone fixation systems, assemblies, devices, and methods of the present disclosure. These examples are included for illustration and are not intended to limit or define the overall scope of the present disclosure. The devices, elements, features, aspects, and/or steps of the systems, components, devices, and methods described in this section may be combined with each other in any suitable combination, and with any devices, elements, features, aspects, and/or steps of the systems, components, devices, and methods described elsewhere in this disclosure.

Example 1.Deformable anchor

This example depicts an exemplary anchor 62 'including a sleeve 82', which sleeve 82 'is deformable by a corresponding locking member 84'. This deformation makes locking member 84 'more resistant to rotation (which would loosen the grip of the anchor on staple 60) and results in a more reliable and stable locking of staple 60 to anchor 62'; see fig. 43-50.

The sleeve 82 'and locking member 84' are similar to the sleeve 82 and locking member 84 (see, e.g., fig. 1-20), and can have any suitable combination of the features described above in sections I and II. For example, the sleeve 82' may have a proximal body 106 distally forming a shoulder 110, and may have a post 108 axially projecting from the shoulder 110. The body 106 may define a transverse aperture 126, such as a slot in the depicted embodiment. The body may also define an axial opening 128, such as an axial bore, intersecting the transverse bore. An externally threaded structure 121 (such as one or more external threads) may be defined by an exterior of the body 106 for attaching the cannula to bone via threaded engagement. The internal threads 90 may be defined by an axial opening 128 inside the body 106 for attaching the sleeve 82' to the locking member 84' by threaded engagement with the at least one external thread 92 of the locking member 84 '. Thus, the locking member 84' may be described as a set screw. Various differences between the anchor 62' of this example and the anchor 62 of section I are described below.

The external thread formation 121 of the sleeve 82' may cover a greater area of the radial periphery of the body 106 relative to the sleeve 82 (compare fig. 44 and 45 with fig. 6 and 7). More specifically, the external thread structure 121 may extend along a majority of a full turn of the helix for each full revolution (full revolution) of the thread. The transverse bore 126 and associated ramp 132 interrupt the thread formation 121. The thread formation may also be interrupted by a self-tapping feature 410 (such as an axial cut) to form a complementary internal thread in the bone as the cannula is driven into the bone (see fig. 45). With this threaded configuration, the cannula 82' is driven into the bone primarily by rotation, and may provide a stronger attachment to the bone than the cannula 82.

The shoulder 110 of the sleeve 82' may be of circular profile rather than flat profile (compare fig. 44 and 45 with fig. 6 and 7). The rounded shoulder configuration may reduce the amount of cortical bone (if any) that needs to be removed from the inner wall of the far cortex of the bone relative to a flat shoulder. Thus, the rounded shoulder reduces the likelihood of weakening or otherwise damaging the far cortex when drilling a cannula in bone. The radius of curvature of the shoulder 110 may approximately match or may be less than the average radius of curvature of the medullary canal in which the sleeve is to be installed in the bone.

The locking member 84 'may have features that provide a tighter threaded engagement with the sleeve 82' relative to the locking member 84 and the sleeve 82 (compare fig. 46 with fig. 11 and 14). The external threads 92 of the locking member 84' may extend along a greater length of the locking member, such as more than half or three-quarters of the length. Likewise, the major diameter 412 of the external threads 92 may taper distally in the leading end region of the locking member 84'. Major diameter 412 may be tapered to match the diameter of unthreaded portion 414 located distally of external threads 92. These features may reduce the risk of cross-threading the external threads 92 with the internal threads 90 of the sleeve 82' and/or may facilitate threading in the wall of the axial opening 128 through the external threads 92, as described further below.

The locking member 84' may have a distal protrusion 156 surrounding a recess 158. The distal protrusion of the locking member 84' may define a sharper annular rim than on the locking member 84 (compare fig. 46 and 47 with fig. 13). When the distal end of the locking member 84' is tightened against the nail, the rim may deform the lateral surface region 416 of the nail 60 (see fig. 47). Such deformation may be facilitated by the difference in stiffness between locking member 84' and staple 60. For example, the nail 60 and the locking member 84' may comprise a titanium alloy and a cobalt-chromium alloy (an alloy of cobalt and chromium), respectively, or the like.

Fig. 48-50 illustrate how the locking member 84 'may be installed in the sleeve 82'. This installation pushes the spike 60 to the distal end of the transverse aperture 126 (compare fig. 48 with fig. 50) and tightly clamps the spike 60 between the sleeve 82' and the locking member 84', optionally with the spike 60 deformed by the locking member 84' as described above. This installation may also deform the wall of the axial opening 128 to form a new internal thread formation 418 inside the sleeve. The internal thread formation 418 is a distal extension of the internal thread 90. The fit between the new internal thread formation 418 and the external thread 92 is tight and better resists any tendency of the locking member 84' to gradually rotate about its long axis after installation and release its grip on the nail.

Fig. 48 shows a nail 60 extending through a sleeve 82'. The locking member 84 'has been translationally mated with the sleeve 82', indicated by the arrow at 420. The complementary threads 90, 92 are positioned for rotational engagement, but have not yet engaged one another. The unthreaded portion 414 fits snugly in the axial opening 128 to ensure that the sleeve 82 'and the locking member 84' are coaxially aligned with one another, which avoids cross threading.

Fig. 49 shows the locking member 84 'in threaded engagement with the sleeve 82' via threads 90, 92 at an intermediate stage of assembly. The locking member 84' has been rotated, indicated by the arrow at 422, to create contact between the distal end of the locking member and the staple 60 such that when the locking member is further advanced by the rotation, the staple is pushed towards the distal end of the transverse aperture 126. The sleeve 82 'and the locking member 84' are interference fit with each other at this stage of installation because the major diameter 412 of the locking member is greater than the diameter of the axial opening 128 (see also fig. 46) away from the internal threads 90. As a result, the locking member 84' exerts tension radially outward on the opposing walls 424 of the axial opening 128, while the sleeve 82' exerts compression radially inward on the locking member 84 '. In response, the sleeve 82' may bulge radially outward, as indicated by the arrow at 426, to slightly increase the width of the transverse aperture 126. Alternatively or additionally, the external threads 92 may deform the wall 424 to form, or at least initially form, the internal thread formation 418 (see also FIG. 50)

Fig. 50 shows locking member 84 'fully advanced by rotation to a seated position that locks staple 60 to sleeve 82'. The staple 60 has been urged into contact with the distal end of the transverse aperture 126 and clamped, and optionally deformed, between the sleeve and the locking member. When the locking member is tightened against the nail 60, the locking member 84 'may place the sleeve 82' under axial tension. This tension urges the wall 424 radially inward against the external threads 92 of the locking member 84', indicated by the arrow at 428, which may deform the wall 424 to form the internal thread formation 418. The sleeve 82' may be formed of a softer material than the locking member 84', such that the sleeve preferentially deforms relative to the locking member 84' when the internal thread formation 418 is formed. For example, the sleeve 82' may comprise a titanium alloy and the locking member may comprise a cobalt chromium alloy or the like.

Example 2.Instrument with eccentric guide axis

This example describes another exemplary embodiment 190 ' "of an instrument for use with the fixation system 50 to facilitate installation of the cannula 82 (or 82') and/or the locking member 84 (or 84') (see parts I, II, and IV, and example 1); see fig. 51-54.

The instrument 190 "' may have any suitable combination of the features described elsewhere herein, including a self-centering guide axis 202 having a rotatably adjustable degree of offset. The instrument 190 "' is most similar to the instrument 190 and may have a clamp portion 192 (see fig. 51) connected to a guide portion 194.

The clamp portion 192 may have a pair of levers 222a, 222b, the pair of levers 222a, 222b being pivotally connected to each other at a fulcrum 224. The lever forms a pair of jaws 196 at one end to grip the bone and a pair of handle members 228 at the other end. The locking mechanism 238, which is configured as a ratchet, allows the levers 222a, 222b to pivot in the closing direction of the jaws 196, rather than the opening direction, i.e., so that the jaws can pivot toward each other, but not away from each other, until the teeth and pawls of the ratchet disengage from each other. In some embodiments, the teeth and pawl of the ratchet may be positioned such that the ratchet cannot lock the jaw 196 against the bone unless the bone has at least a threshold diameter. The threshold diameter may be selected to ensure that the bone is locally wide enough to allow drilling and cannulation to be installed without significant risk of iatrogenic fracture of the bone.

The guide portion 194 may be connected to the clamp portion 192 with a retainer 218 (see fig. 52). Retainer 218 may remain on a central plane of clamp portion 192 as jaws 196 open and close. More specifically, the retainer 218 may be pivotally connected to the clamp portion 192 on the axis of the fulcrum 224, and may also be coupled to the levers 222a, 222b by a pair of pivotally connected link members 220. The pivotable connection 232 between the link members 220 can slide along the slot 236 defined by the retainer 218 to retain the retainer (and guide portion 194) on the central plane of the clamp portion 192. The retainer 218 may also define one or more channels 200 for receiving wire members that couple the retainer (and thus the instrument) to the bone. Each channel may extend from the proximal surface area to the distal end of the retainer. The distal end of the retainer 218 may be configured to contact the bone and may be flush with the distal end of the guide portion 194. The retainer 218 may surround at least an axial region of the guide portion. Additional aspects of the self-centering mechanism and channel 200 for guiding the axis are described above in section IV.

The guide portion 194 may be rotatably connected to the holder 218 (see fig. 52 and 53). The guide portion may include a tube 262, the tube 262 defining the eccentrically positioned guide channel 214 and the guide axis 202 extending through the guide channel 214. Tube 262 may be at least partially disposed in an opening 284 defined by holder 218 and may be connected to the holder by a complementary retention feature that restricts axial removal of tube 262 from holder 218. In the depicted embodiment, the retention feature comprises a protrusion 430 of the retainer 218 that is received in a groove 432 defined by the exterior of the tube 262. The groove 432 may extend circumferentially around the tube 262 to allow rotation of the tube about its central long axis. Groove 432 may open axially at release location 434, which allows tube 262 to be axially removed from retainer 218 when release location 434 is rotated into alignment with protrusion 430.

Guide portion 194 and retainer 218 may collectively form gauge 436 to measure and indicate the current offset of guide axis 202 from the central plane of instrument 190' ", as determined by the rotational orientation of tube 262 (see fig. 51-54). The scale 438 may be displayed by the guide portion 194 and the indicator 440 may be displayed by the holder 218, or vice versa (see fig. 51 and 52). The scale may have reference marks and/or characters (e.g., letters, numbers, and/or symbols) or the like. For example, in the depicted embodiment, the scale 438 has the numbers 2, 1, 0, 1, and 2, which are arranged in this order along the circumferential path on the tube 262. Each number represents the distance (in millimeters) of the guide axis 202 from the central plane of the instrument 190' ". The number spacing is not uniform; in either rotational direction, tube 262 will rotate through a greater angle by changing the degree of offset from 1 millimeter to 2 millimeters relative to a change in the degree of offset from 0 millimeters to 1 millimeter.

The guide portion 194 may be translationally and/or rotationally movable to a plurality of predetermined offset positions of the guide axis that are offset relative to the central plane 230. The predetermined offset may result from features of the guide portion 194 and features of the retainer 218 that are complementary to one another. For example, the guide portion 194 may be retained by a complementary feature at a predetermined rotational position corresponding to the offset measured by the gauge 436 (see fig. 53 and 54). The stopper 442 may prevent rotation of the guide portion 194 at each predetermined position, and the stopper may be released by manually applying sufficient torque to the guide portion 194. In the depicted embodiment, the retainer 442 is a spring-biased ball (spring-biased ball) attached to the retainer 218 with a screw 444. The exterior of the tube 262 defines a plurality of complementary recesses 446, each sized to receive a retainer 442. (there are five depressions 446 in the depicted embodiment.) each depression 446 is positioned at the same radial orientation as one of the numbers on scale 438.

Instrument 190 "' may be formed primarily of radiolucent material and may include one or more radiopaque members to allow visualization with fluoroscopy. In the depicted embodiment, the radiopaque members are an upper ring 448 and a lower ring 450, each of the upper ring 448 and the lower ring 450 centered about the guide axis 202 (see fig. 53). The rings 448, 450 can be placed under fluoroscopyThis coaxial alignment ensures that the viewing axis for fluoroscopy is parallel to the guide axis 202, and can then be compared to the position of the nail (see also fig. 29). In an exemplary embodiment, the rings 448, 450 are formed of metal and the other portions of the instrument 190' "are formed of carbon fiber. In some embodiments, the radiopaque member is not centered on the guide axis 202 and does not rotate with the guide portion 194. For example, a radiopaque member may be mounted to the holder 218.Example 3.Drill pair for near and far cortical hole formation

This example depicts a near cortical drill 460 and a far cortical drill 462. This example also describes a two-drill procedure that uses drills 460, 462 to sequentially form respective holes 160, 161 of different diameters in the proximal and distal cortex 118, 120 of a bone (e.g., fibula 54) to receive correspondingly sized regions of the cannula 82 (or 82') (provided by the body 106 and post 108); see fig. 55-59.

The two-drill process described herein may be advantageous over the single-drill process (see fig. 21) using drill 204. The single drilling process is described in more detail in U.S. patent application serial No. 15/728,247 filed on 2017, 10, 9, which is incorporated herein by reference. Advantages of the double drilling process may include more reliable formation of narrower holes 161 without unduly weakening the far cortex 120 or inadvertently over drilling the far cortex 120. The two drilling process is accomplished by the rounded shoulder 110 of the cannula 82', which reduces the amount of cortical bone (if any) that needs to be removed from the distal cortex 120 in order to create the appropriate space for receiving the shoulder 110.

Figures 55 and 57 show, respectively, an isolated near cortical drill 460 (figure 55) and a near cortical drill 460 (figure 57) that resists further advancement into the bone 54. The near cortex drill 460 has a shaft 464 equipped with a distal pointed tip 466. The shaft 464 defines one or more grooves (flute)468 that form at least one cutting edge 470 in the drill's distal bore portion 472 and proximal bore portion 474. The drill portions are collectively configured to drill a wider hole 160 through the near cortex to receive the body 106 of the cannula 82 (or 82'). More specifically, the distal drilling portion 472 forms a narrower hole in the proximal cortex 118 that is reamed by the proximal drilling portion 474 to form the wider hole 160.

The stop member 476 may be positioned radially outward of the shaft 464 and may be formed integrally with the shaft or separately therefrom. If formed separately, the stop member 476 may have an adjustable position along the shaft 464. The stop member is configured to establish a depth at which the near cortical drill 460 is impeded from further advancement into the bone 54. When drilling is completed with the near cortical drill 460, advancement is impeded by contact between the proximal ends of the tubes 262 of the guide portion 194 of any of the clamp/guide instruments disclosed herein. The axial position of the stop member 476 along the shaft 464 ensures that further distal travel of the drill 460 is impeded after the proximal drilling portion 474 has drilled the wider hole 160 completely through the proximal cortex 118, but before the leading end of the proximal drilling portion 474 reaches the distal cortex 120 (see fig. 57). The axial position for the stop member may be selected before or after manufacture of the drill based on a range of bone sizes present in a population of potential subjects, or based on a measurement of at least one bone size specific to a particular subject that will receive the cannula. The distal drilling portion 472 may or may not drill a blind distal cortex hole 478 depending on whether the stop member 476 prevents the advancement of a drill before the distal drilling portion reaches the distal cortex 120 (see fig. 57).

Fig. 56 and 58 show the far cortical drill 462 in isolation (fig. 56) and the far cortical drill 462 prevented from advancing further into the bone 54 (fig. 58), respectively. The distal cortical drill 462 has a shaft 480 equipped with a distal pointed tip 482 (e.g., a faceted (trocar) tip). The tip 482 forms a proximal bore portion 484 to drill a narrower hole 161 in/through the distal cortex 120 (see fig. 58). The shaft 480 defines one or more grooves 486, the one or more grooves 486 forming at least one cutting edge 488 in the distal counterbore portion 490 of the drill. The proximal reaming portion 490 is side-cutting, which allows the reaming portion to effectively widen the area of the medullary canal 64, if desired, to achieve a better fit of the circular shoulder 110 of the sleeve 82' against the wall of the medullary canal. However, the proximal reaming portion is configured to avoid end-cutting so that the proximal reaming portion cannot axially drill into the distal cortex 120 at the narrower bore 161. Thus, when the configuration of fig. 58 is reached, advancement of the far cortical drill 462 is prevented. The holes 160, 161 formed by the drills 460, 462 are shown in fig. 59 after the drill 462 is removed.

Example 4.Alternative embodiment I

This section describes selected embodiments of the present disclosure as a series of indexed paragraphs.

Paragraph a1. a system for bone fixation, the system comprising: (i) an instrument having a pair of jaws configured to engage opposite sides of a bone, the jaws being coupled to a guide portion defining a guide axis such that when such jaws are opened and closed, the guide axis remains within a central plane located between and equidistant from the jaws; (ii) a cannula configured to be placed transversely in a bone on a guide axis; (iii) a nail configured to be longitudinally placed in a medullary canal of a bone such that the nail extends through the cannula; and (iv) a locking member that locks the staple to the cannula.

Paragraph a2. the system of paragraph a1, further comprising at least one drill, wherein the guide portion is configured to guide drilling of at least one hole in the bone on the guide axis using the at least one drill, and wherein the at least one hole comprises a hole having a diameter corresponding to a diameter of the cannula.

Paragraph a3. the system of paragraph a2, wherein the at least one drill is a stepped drill having a proximal drill portion configured to form a wider hole in a proximal cortex of the bone and a distal drill portion configured to form a narrower hole in a distal cortex of the bone, and wherein the cannula includes a body having a diameter corresponding to the wider hole and a post having a diameter corresponding to the narrower hole.

Paragraph a4. the system of paragraph a2, wherein the at least one drill includes a first drill configured to form a wider hole in a near cortex of the bone and a second drill configured to form a narrower hole in a far cortex of the bone, and wherein the cannula includes a body having a diameter corresponding to the wider hole and a post having a diameter corresponding to the narrower hole.

Paragraph a5. the system of any of paragraphs a1 to a4, wherein the cannula is configured to be advanced over the guide axis, through the guide portion and into the bone.

Paragraph a6. the system of any of paragraphs a1 to a5, wherein the guide portion has a tube defining a guide axis and configured to be movable relative to the jaws when the jaws are held in engagement with the bone to offset the guide axis from the central plane.

Paragraph A7. the system of paragraph a6, wherein the tube is adjustable to offset the guide axis from the central plane in a direction opposite from the central plane.

Paragraph A8. the system of any one of paragraphs a1 to a7, wherein the guide portion comprises a tube coupled to the jaw via a retainer, and wherein the tube is configured to move relative to the retainer to offset the guide axis from the central plane.

Paragraph A9. the system of any one of paragraphs a1 to a8, wherein the jaws are connected to each other at a pivot axis, and wherein the central plane contains the pivot axis.

Paragraph a10. the system of any of paragraphs a1 to a9, wherein the clamping jaw defines a plane parallel to and spaced from the guide axis.

Paragraph a11. the system of any of paragraphs a 1-a 10, wherein the instrument defines a pair of channels configured to receive a pair of wire members and guide the wire members through the bone in a non-parallel trajectory to stabilize the instrument on the bone.

Paragraph a12. the system of paragraph a11, wherein the channel is configured to guide the wire member through the bone in a trajectory that avoids a medullary canal of the bone.

Paragraph a13. the system of paragraph a11 or a12, wherein the trajectories are closest to each other before reaching the bone.

Paragraph a14. the system of any of paragraphs a1 to a13, wherein the instrument has a gauge that measures the local width of the bone engaged by the jaws.

Paragraph a15. the system of paragraph a14, wherein the gauge is configured to indicate whether the local width of the bone is sufficient for safe installation of the cannula.

Paragraph a16. the system of paragraph a15, wherein the gauge has a color coding to indicate whether the local width of the bone is sufficient.

Paragraph a17. the system of any of paragraphs a 1-a 16, further comprising a set of sleeves having diameters that are the same as one another and lengths that are different from one another and including the sleeves, each sleeve of the set of sleeves defining an aperture through which a staple is configured to extend, the aperture of each sleeve having a different size measured parallel to the long axis of the sleeve and corresponding to the different lengths of the sleeves.

The system of any of paragraphs a1 to a17, further comprising any other definition of any other indexed paragraph of part VIII.

Paragraph b1. a method of fixing a bone, the method comprising: (i) engaging an opposite side of a bone with a jaw of an instrument having a guide portion defining a guide axis, the jaw being coupled or configured to be coupled to the guide portion such that when such jaw is opened and closed, the guide axis remains within a central plane located between and equidistant from the jaws; (ii) drilling at least one hole transversely in the bone on the guide axis; (iii) placing a cannula into the bone at the at least one hole; (iv) longitudinally advancing a nail in a medullary canal of a bone such that the nail extends through the cannula; and (v) locking the nail to the sleeve.

Paragraph B2. the method of paragraph B1, wherein the jaws define a clamping plane that is orthogonal to the central plane and parallel to and spaced from the guide axis.

The method of paragraph B2, wherein the step of engaging includes the step of orienting the clamping plane substantially orthogonal to the long axis of the bone.

Paragraph B4. the method of any one of paragraphs B1 through B3, wherein the jaws are pivotable relative to each other about a pivot axis defined by the instrument, wherein the pivot axis is inclined relative to the guide axis, and wherein the step of engaging includes the step of orienting the pivot axis obliquely relative to a long axis defined by the bone.

The method of any of paragraphs B5. B1 to B4, further comprising the step of offsetting the guide axis from the central plane while the jaws remain engaged with the bone prior to the step of drilling.

The method of paragraph B6. paragraph B5, further comprising the step of fluoroscopically viewing the alignment between the nail or reamer and at least a portion of the guide portion, wherein the step of offsetting the guide axis improves the alignment.

The method of paragraph B7., paragraphs B5 or B6, wherein the step of offsetting comprises the step of moving at least a portion of the guide portion relative to the jaw such that the guide axis is parallel to and spaced from the central plane.

Paragraph B8. the method of paragraph B7, wherein the step of moving includes the step of rotating at least a portion of the guide portion relative to the jaw.

The method of paragraph B9. paragraph B8, wherein the step of rotating includes the step of rotating at least a portion of the guide portion about an axis of rotation parallel to and spaced from the guide axis.

Paragraph B10. the method of paragraph B8, wherein the step of moving includes the step of producing a net translational displacement of at least a portion of the guide portion relative to the jaw.

The method of any of paragraphs B11. B1-B10, further comprising the step of driving at least one wire member through the bone on a trajectory defined by the instrument to stabilize the instrument relative to the bone.

Paragraph B12. the method of paragraph B11, wherein the step of driving includes the step of driving a pair of wire members through the bone on non-parallel trajectories defined by the instrument.

Paragraph B13. the method of paragraph B12, wherein the trajectories are closest to each other before reaching the bone.

The method of any of paragraphs B14. B11-B13, wherein each trajectory is defined by a corresponding channel of the instrument, and wherein each wire member extends through the corresponding channel after the step of driving.

Paragraph B15. the method of any one of paragraphs B11 to B14, wherein each wire member is a k-wire.

The method of any of paragraphs B16. B1-B15, further comprising the step of measuring the local width of the bone between the opposite sides engaged by the jaws using a gauge of the instrument.

Paragraph B17. the method of paragraph B16, wherein the gauge indicates the local width numerically and/or indicates the local width as a color.

A method as paragraph B18, any of paragraphs B1 to B17, further comprising any other definition of any other indexed paragraph of part VIII.

Paragraph c1. a system for bone fixation, the system comprising: (i) an instrument including a pair of jaws configured to engage opposite sides of a bone, and a guide portion coupled to the jaws and defining a guide axis, the instrument configured to guide a pair of wire members through the bone on a pair of non-parallel trajectories to stabilize the instrument relative to the bone; (ii) a cannula configured to be placed transversely in the bone via at least one hole drilled in the bone from the guide portion on the guide axis; (iii) a nail configured for longitudinal placement in a medullary canal of a bone such that the nail extends through the cannula; and (iv) a locking member configured to lock the staple to the sleeve.

Paragraph C2. the system of paragraph C1, wherein the instrument has a pair of channels defining the pair of non-parallel trajectories.

The system of paragraph C3., paragraphs C1 or C2, wherein the pair of non-parallel trajectories are configured to be closest to each other before reaching the bone.

Paragraph C4. the system of any of paragraphs C1 to C3, wherein the instrument comprises a pair of levers pivotally connected to each other and forming jaws, wherein the guide portion is connected to the levers via a holder, and wherein the holder defines each trajectory.

Paragraph C5. the system of paragraph C4, wherein the guide portion includes a tube defining a channel centered on the guide axis, and wherein the retainer surrounds the tube.

The system of any of paragraphs C6. to C1 to C5, wherein each trajectory is configured to avoid a medullary canal of a bone.

The system of any of paragraphs C7. to C1 to C6, further comprising the pair of wire members, wherein each wire member is a k-wire.

Paragraph C8. the system of any of paragraphs C1 to C7, further comprising any other definition of any indexed paragraph of section VIII.

Paragraph d1. a method of fixing a bone, the method comprising: (i) engaging an opposite side of a bone with a jaw of an instrument having a guide portion coupled to the jaw and defining a guide axis; (ii) driving a pair of wire members into the bone after the step of engaging such that the wire members extend through the instrument and the bone on non-parallel trajectories defined by the instrument to stabilize the instrument relative to the bone; (iii) drilling at least one hole transversely in the bone on the guide axis; (iv) placing a cannula into the bone via the at least one hole; (v) longitudinally advancing a nail in a medullary canal of a bone such that the nail extends through the cannula; and (vi) locking the nail to the sleeve.

The method of paragraph D2. paragraph D1 wherein the step of driving includes the step of guiding each wire member advancement to the bone with a channel defined by the instrument.

Paragraph D3. the method of paragraph D2, wherein the instrument has a pair of levers forming jaws, wherein the pair of levers are coupled to the guide portion via a retainer, and wherein the step of guiding advancement of each wire member includes the step of guiding advancement of the wire member with a channel defined by the retainer.

The method of paragraph D4. of any one of paragraphs D1 to D3, further comprising any other definition of any other indexed paragraph of section VIII.

Paragraph e1. a system for bone fixation, the system comprising: (i) a nail configured for longitudinal placement in a medullary canal of a bone; (ii) a sleeve having a tail portion and a nose portion, the tail portion forming a shoulder adjacent the nose portion and defining a transverse aperture through which the staple is configured to extend, the nose portion being elongate and generally cylindrical, and (iii) a locking member configured to lock the staple to the sleeve.

The system of paragraph E2. paragraph E1, wherein the tail portion includes a generally cylindrical body.

Paragraph E3. the system of paragraphs E1 or E2, wherein the tail portion tapers or terminates abruptly to form a shoulder.

The system of any of paragraphs E4. E1-E3, wherein the tail portion comprises one or more lateral protrusions configured to attach the cannula to the near cortex of the bone.

The system of paragraph E5. paragraph E4, wherein at least one of the lateral projections forms at least a portion of an entrance to the transverse orifice.

The system of paragraph E6., paragraph E4 or E5, wherein the one or more lateral protrusions form and/or are configured to function as external threads.

The system of any of paragraphs E7. E4 to E6, wherein the one or more lateral protrusions comprise a plurality of teeth.

Paragraph E8. the system of paragraph E7, wherein the lateral projections form two or more sets of teeth that are circumferentially spaced from each other on the tail portion, and wherein the teeth of different sets are arranged on the same helical path as each other.

Paragraph E9. the system of paragraph E8, wherein the plurality of teeth comprises an axial row of teeth arranged parallel to the long axis of the sleeve.

The system of any of paragraphs E10, E4-E9, wherein the one or more lateral protrusions define a plurality of axial rows of teeth.

The system of any of paragraphs E11, E1 to E10, wherein the shoulder is spherical or planar.

The system of any of paragraphs E12, E1-E11, wherein the tail portion of the sleeve further defines an axial bore intersecting the transverse bore and having internal threads, and wherein the locking member has external threads complementary to the internal threads.

The system of any of paragraphs E1-E12, wherein the distal end of the cannula is not cylindrical.

The system of any of paragraphs E14. E1-E13, wherein the sleeve defines a long axis, and wherein the transverse aperture is elongated parallel to the long axis and has a tapered entrance.

The system of any of paragraphs E15. the system of any of paragraphs E1-E14, wherein the transverse bore has opposite ends spaced apart from each other parallel to a through axis of the transverse bore, and wherein each of the opposite ends is circumferentially inclined to form a widened inlet.

The system of any of paragraphs E16. the system of any of paragraphs E1-E15, wherein the transverse aperture has an inlet, and wherein the inlet has a length measured parallel to the long axis of the cannula that is at least half the length of the tail portion measured parallel to the long axis.

The system of any of paragraphs E17. the system of any of paragraphs E1 to E16, wherein the transverse orifice has an inlet, wherein the inlet has a maximum width measured parallel to a diametric axis of the cannula that is orthogonal to the long axis of the cannula and orthogonal to a through axis of the orifice, and wherein the maximum width is at least half of the average diameter of the tail portion.

The system of any of paragraphs E1-E17, wherein the anterior region of the staple has a main portion defining a long axis and a distal end offset from the long axis.

The system of paragraph E18, wherein the terminal end is elongated substantially parallel to the major axis of the main portion.

The system of paragraph E20. paragraph E18 or E19, wherein the main portion has a uniform diameter, and wherein the ends are tapered.

The system of any of paragraphs E21. E18-E20, wherein the tail region of the staple is curved in a plane, and wherein the tip is offset from the main portion in the plane.

The system of any of paragraphs E22. E18 to E21, wherein the terminus is less than half the length of the main portion.

The system of any of paragraphs E23. E1-E22, wherein the nail has a head and a shaft, wherein the head defines a plurality of openings configured to receive fasteners that attach the head to the bone, and wherein the sleeve and the locking member are configured to attach the shaft to the bone.

The system of any of paragraphs E24, E1 to E23, further comprising any other definition of any other indexed paragraph of section VIII.

Paragraph f1. a method of fixing bone, the method comprising: (i) drilling a hole into the bone on an axis to form a wider hole through a near cortex of the bone and a narrower hole in and/or through a far cortex of the bone; (ii) selecting a sleeve having a tail portion and a nose portion, the tail portion having a diameter corresponding to the wider bore and the nose portion having a diameter corresponding to the narrower bore, the tail portion forming a shoulder adjacent the nose portion; (iii) driving the cannula as a unit into the bone drilled on the axis until the shoulder engages the distal cortex to prevent further advancement of the cannula; (iv) longitudinally advancing the nail in the medullary canal such that the nail extends through the cannula; and (v) locking the nail to the sleeve.

Paragraph F2. the method of paragraph F1 wherein the step of drilling the bone includes the step of forming a cylindrical wider bore and an at least partially cylindrical narrower bore.

Paragraph F3. the method of paragraphs F1 or F2 wherein the step of drilling the bone is performed with a first drill to form a wider hole and with a second drill to form a narrower hole.

Paragraph F4. the method of paragraph F3, further comprising the step of mounting the guide wire on an axis prior to the step of drilling, wherein the step of drilling is performed on the guide wire using the cannulated first drill and/or the cannulated second drill.

Paragraph F5. the method of paragraph F1 or F2 wherein the step of drilling is performed with a step drill that forms a wider hole and a narrower hole.

Paragraph F6. the method of any one of paragraphs F1 to F5, wherein the step of drilling the hole includes the step of forming a recessed region on an inner side of the far cortex adjacent the narrower hole, and wherein the recessed region is complementary to the tail portion of the cannula at the shoulder.

Paragraph F7. the method of any one of paragraphs F1 to F6, wherein the tail portion tapers or terminates abruptly to form a shoulder.

Paragraph F8. the method of any one of paragraphs F1 to F7, wherein the step of driving the sleeve includes the step of rotating the sleeve about its long axis more than one full turn.

Paragraph F9. the method of any one of paragraphs F1 through F8, wherein the tail portion has one or more lateral projections, and wherein the step of driving the cannula includes the step of engaging the near cortex of the bone with the one or more lateral projections.

Paragraph F10. the method of paragraph F9, wherein the step of engaging the near cortex includes the step of pushing one or more lateral projections into the cortical bone at the wider aperture.

Paragraph F11. the method of any of paragraphs F1 to F10, wherein the step of driving comprises the step of pushing or tapping the cannula to push the cannula into the bone.

Paragraph F12. the method of any of paragraphs F1 to F11, wherein the nail has a tail region and a front region, wherein the step of locking the nail comprises the step of clamping a portion of the front region of the nail between the sleeve and the locking member, the method further comprising the step of attaching the tail region of the nail to the bone using one or more fasteners extending into an opening defined by the tail region.

Paragraph F13. the method of paragraph F12, wherein the tail region forms a wider head, and wherein the head region forms a narrower stem.

The method of any of paragraphs F1 to F13, further comprising any other definition of any other indexed paragraph of part VIII.

Paragraph G1. A system for bone fixation, the system comprising: (i) an instrument having a clamp portion coupled to a guide portion defining a guide axis, the clamp portion including a pair of jaws configured to engage opposite sides of a bone, wherein the instrument has a gauge to measure a local width of the bone between the jaws; (ii) a cannula configured to be placed transversely in the bone via at least one hole drilled in the bone from the guide portion on the guide axis; (iii) a nail configured for longitudinal placement in a medullary canal of a bone such that the nail extends through the cannula; and (iv) a locking member configured to lock the staple to the sleeve.

The system of paragraph G2. paragraph G1, wherein the meter has a color coding configured to indicate the local width as one of two or more different colors.

The system of paragraph G3. paragraph G2, wherein each different color represents a range of widths, and wherein the ranges of widths of the two or more different colors do not overlap with each other.

Paragraph G4. the system of paragraphs G2 or G3 wherein the meter indicates a smaller width as red and a larger width as green.

Paragraph G5. the system of paragraph G4, wherein the gauge indicates the intermediate width as yellow or orange.

Paragraph G6. the system of paragraphs G4 or G5 wherein the red color corresponds to a local width for which installation of the ferrule is not recommended.

Paragraph G7. the system of any one of paragraphs G1 to G6, wherein the gauge comprises a graduated scale.

Paragraph G8. the system of paragraph G7, wherein the graduated scale includes one or more numbers indicating local widths in terms of standard units of measurement.

The system of any of paragraphs G1 to G8 of paragraph G9., further comprising any other definitions of any other indexed paragraph of section VIII.

Paragraph h1. a method of fixing bone, the method comprising: (i) engaging an opposite side of a bone with a jaw of an instrument having a guide portion coupled to the jaw and defining a guide axis; (ii) reading a gauge of the instrument that measures a local width of the bone between the jaws; (iii) if the gauge indicates that the local width is too small, moving the jaw to a different position on the bone; (iv) drilling at least one hole transversely in the bone on the guide axis; (v) placing a cannula into the bone at the at least one hole; (vi) longitudinally advancing a nail in a medullary canal of a bone such that the nail extends through the cannula; and (vii) locking the nail to the sleeve.

Paragraph H2. the method of paragraph H1, wherein the step of reading the meter comprises the step of reading a color from the meter.

Paragraph H3. the method of paragraphs H1 or H2, further comprising any other definition of any other indexed paragraph of section VIII.

Paragraph I1. a method of fixing bone, the method comprising: (i) engaging an opposite side of a bone with a jaw of an instrument having a guide portion coupled to the jaw and defining a guide axis; (ii) placing a nail or reamer along the medullary canal of the bone; (iii) determining the extent to which the nail or reamer and the guide portion are aligned with one another by fluoroscopy; (iv) repositioning the guide axis to improve the degree of alignment, if not sufficient, by moving at least a portion of the guide portion relative to the jaws while such jaws remain engaged with the bone; (v) retracting the nail or reamer; (vi) drilling a hole in the bone from the guide portion on the guide axis; (vii) placing a cannula into a bone of a borehole; (viii) longitudinally advancing the nail in the medullary canal such that the nail extends through the cannula; and (ix) locking the nail to the sleeve.

Paragraph I2. the method of paragraph I1 wherein the step of placing the sleeve includes the step of passing the sleeve through the guide portion on the guide axis.

Paragraph I3. the method of paragraphs I1 to I2, further comprising any other definition of any other indexed paragraph of section VIII.

Paragraph j1. a system for bone fixation, the system comprising: (i) a cannula configured to be positioned in a bone bi-cortical to span a medullary canal of the bone, the cannula defining an axial aperture intersecting the transverse aperture; (ii) a nail having a leading region and a trailing region, the nail configured to be placed along a medullary canal such that the leading region of the nail extends through the cannula via the transverse aperture, the trailing region defining one or more openings configured to receive fasteners that attach the trailing region to the bone; and (iii) a locking member configured to be received in the axial bore to lock the forward region of the staple to the sleeve; wherein the front region of the staple has a main portion and a tip portion, the tip portion being laterally offset from the main portion.

The system of paragraph J2. paragraph J1, wherein the tip portion is substantially parallel to the main portion.

Paragraph J3. the system of paragraphs J1 or J2, wherein the main portion has a uniform diameter, and wherein the end portions are tapered.

The system of any of paragraphs J4. to J1 to J3, wherein the tail portion is curved in a plane, and wherein the tip portion is offset from the main portion in the plane.

The system of any of paragraphs J5. J1 to J4, wherein the end portion is less than half the length of the main portion.

Paragraph J6. the system of any one of paragraphs J1 through J5, further comprising any other definition of any other indexed paragraph of section VIII.

Paragraph K1. a method of fixing bone, the method comprising: (i) placing a cannula into the bone such that the cannula spans a medullary canal of the bone, the cannula defining an axial aperture intersecting the transverse aperture; (ii) selecting a staple comprising a leading region and a trailing region, the leading region having a main portion and a tip offset from a major axis of the main portion; (iii) advancing the tip along a medullary canal of the bone until the tip is proximate the transverse portal; (iv) rotating the spike about the long axis, if necessary, to improve alignment of the tip with the transverse aperture; (v) passing the tip through the transverse aperture; (vi) locking the front region of the nail to the sleeve using a locking member received in the axial bore of the sleeve; and (vii) attaching the tail region of the nail to the bone.

Paragraph L1A system for bone fixation includes (i) an instrument having a clamp portion coupled to a guide portion, the guide portion defining a guide axis, the clamp portion including a pair of jaws configured to clamp opposite sides of a bone, at least a portion of the guide portion configured to be repositioned relative to the clamp portion to offset the guide axis while the jaws remain stationary, (ii) a cannula configured to be placed in the bone (a) through the guide portion on the guide axis and/or (b) via at least one hole drilled in the bone from the guide portion on the guide axis, the cannula defining an aperture, and (iii) a nail configured to be placed along a medullary canal of the bone such that the nail extends through the aperture of the cannula.

Paragraph L2 the system of paragraph L1, wherein the guide portion defines a channel centered on the guide axis, and wherein the guide portion is radiopaque around the channel.

Example 5.Alternative embodiment II

This section describes additional alternative embodiments of the present disclosure as a series of indexed paragraphs.

Paragraph 1. a system for bone fixation, the system comprising: (A) a cannula configured to be at least partially placed into at least one hole drilled in a bone; (B) a nail configured to be placed along a medullary canal of a bone such that the nail extends through the cannula; and (C) a locking member configured to lock the staple to the sleeve.

Paragraph 2. the system of paragraph 1, further comprising an instrument including a guide portion defining a guide axis and configured to be coupled to the bone such that the guide axis extends across the bone, and wherein the cannula is configured to be placed into at least one hole drilled in the bone along the guide axis.

Paragraph 3. the system of paragraph 2, wherein the instrument comprises a pair of jaws, and wherein the jaws are coupled to the guide portion and configured to engage the bone such that the instrument is coupled to the bone, and wherein optionally the jaws are movable relative to each other about a pivot axis.

Paragraph 4. the system of paragraph 3, wherein the guide axis continues to lie in a central plane positioned between and equidistant from the jaws as the jaws open and close, and wherein optionally the jaws are movable relative to each other about a pivot axis lying in the central plane.

Paragraph 5, paragraph 3 or paragraph 4, wherein the instrument has a pair of levers pivotally connected to one another, wherein the guide portion is coupled to the pair of levers via a holder for the guide portion, wherein the levers are coupled to the holder by respective link members having pivotable connections to one another, and wherein the pivotable connections of the link members move along slots defined by the holder as the jaws open and close, thereby ensuring that the guide portion remains equidistant from the jaws regardless of the degree to which the jaws are open.

Paragraph 6 the system of any of paragraphs 3 to 5, wherein the guide portion is configured to be movable from a first position to at least one second position when the jaw remains engaged with the bone, wherein the guide portion is coupled to the jaw in each of the first and second positions, wherein the guide axis in the first position of the guide portion lies within a central plane between the jaws, and wherein the guide axis in each second position of the guide portion is parallel to but offset from the central plane and the guide axis in the first position of the guide portion.

Paragraph 7. the system of paragraph 6, wherein the guide portion is configured to be movable from the first position to each of the second positions while the guide portion remains coupled to the jaw.

Paragraph 8 the system of paragraph 6 or 7, wherein the guide portion is movable to at least one third position, and wherein the guide axis in each second position of the guide portion and the guide axis in each third position of the guide portion are parallel to each other but offset from the central plane in opposite directions.

Paragraph 9 the system of any of paragraphs 6 to 8, wherein the guide portion is movable to produce a plurality of offsets of the guide axis from the central plane, wherein the guide portion is coupled to the jaw via the retainer, and wherein the plurality of offsets are predefined by features of the guide portion and the retainer that are complementary to each other.

Paragraph 10 the system of paragraph 9, wherein the plurality of offsets comprises predetermined offsets of 1 mm and 2 mm from the central plane.

Paragraph 11 the system of any of paragraphs 6 to 10, wherein the instrument has a gauge to indicate the current offset of the guide axis from the central plane.

Paragraph 12 the system of any of paragraphs 2 to 11, wherein the instrument has a guide portion configured to rotate relative to the jaws about an axis parallel to but spaced from the guide axis to move the guide portion from the first position to each of the second positions.

Paragraph 13 the system of any of paragraphs 2 to 12, wherein the instrument is at least predominantly radiolucent.

Paragraph 14 the system of paragraph 13, wherein the instrument has a guide portion defining a guide axis, and wherein the guide portion includes a radiopaque member centered on the guide axis.

Paragraph 15 the system of paragraph 14, wherein the radiopaque member is a radiopaque ring, and wherein the guide portion comprises a pair of radiopaque rings, each ring centered on and spaced apart from each other along the guide axis.

Paragraph 16 the system of any of paragraphs 2 to 15, wherein the instrument defines at least one wire receiving channel configured to guide a wire member into the bone to couple the instrument to the bone with the wire member, and wherein optionally the instrument defines a pair of wire members configured to guide the pair of wire members into the bone on non-parallel trajectories to couple the instrument to the bone with each wire member.

Paragraph 17. the system of paragraph 16, wherein each wire receiving channel is configured to guide a wire member through the bone on a trajectory that avoids a space in the medullary canal to be occupied by the nail.

Paragraph 18. the system of paragraph 16 or 17, wherein the instrument comprises a pair of levers pivotally connected to each other, wherein each lever provides one of the jaws, wherein the guide portion is connected to the lever via a retainer for the guide portion, and wherein the retainer defines each wire receiving channel.

Paragraph 19. the system of paragraph 18, wherein the distal end of the guide portion is flush with the distal end of the retainer.

Paragraph 20 the system of paragraph 19, wherein the retainer has a proximal surface area facing away from the distal end of the retainer, and wherein each wire receiving channel extends through the retainer from the proximal surface area of the retainer to the distal end of the retainer.

Paragraph 21 the system of any of paragraphs 18 to 20, wherein the retainer surrounds at least an axial region of the guide portion.

Paragraph 22 the system of any of paragraphs 16 to 21, wherein the pair of wire-receiving channels are configured such that the non-parallel trajectories are closest to each other before reaching the bone from the instrument.

Paragraph 23. the system of paragraph 22, wherein the pair of wire-receiving channels are configured such that the non-parallel trajectories are closest to each other inside the instrument.

Paragraph 24 the system of any of paragraphs 16 to 23, further comprising wire members, wherein each wire member is a k-wire.

Paragraph 25 the system of any of paragraphs 1 to 24, wherein the at least one hole comprises a wider hole and a narrower hole, the system further comprising one or more drills configured to drill the wider hole along the guide axis in a near cortex of the bone and to drill the narrower hole along the guide axis in a far cortex of the bone, the cannula comprising a tail portion having a diameter corresponding to the wider hole and a front portion having a diameter corresponding to the narrower hole.

Paragraph 26. the system of paragraph 25, wherein the one or more drills include a first drill that drills a wider hole and a second drill that drills a narrower hole.

Paragraph 27. the system of paragraph 26, wherein the first drill includes a drill portion to drill a wider hole, and further comprising a stop member configured to contact an instrument to prevent axial advancement of the drill portion to the far cortex of the bone.

Paragraph 28 the system of paragraph 26 or 27, wherein the second drill includes a drilling portion to drill the narrower hole and a reaming portion to enlarge a region of the medullary canal adjacent to the narrower hole.

Paragraph 29 the system of any of paragraphs 1 to 28, wherein the sleeve has an external thread configuration to engage the bone at an aperture in the at least one aperture.

Paragraph 30 the system of any of paragraphs 1 to 29, wherein the cannula is configured to be advanced along the guide axis through the guide portion of the instrument and into the bone.

Paragraph 31 the system of any of paragraphs 1 to 30, wherein the sleeve comprises a body having a shoulder, and further comprises a post projecting distally from the shoulder.

Paragraph 32. the system of paragraph 31, wherein the shoulder has a rounded profile resulting from a proximal to distal reduction in diameter of the leading end region of the body.

Paragraph 33 the system of paragraph 31 or 32, wherein the column is cylindrical.

Paragraph 34 the system of any of paragraphs 1 to 33, wherein the sleeve defines a long axis and further defines a transverse aperture through which the staple is configured to extend, and wherein the transverse aperture is elongated parallel to the long axis of the sleeve.

Paragraph 35 the system of paragraph 34, wherein the transverse bore has an inclined entrance.

Paragraph 36 the system of any of paragraphs 1 to 35, wherein the locking member comprises a set screw having an external thread complementary to an internal thread of the sleeve.

Paragraph 37 the system of paragraph 36, wherein the sleeve defines a transverse aperture and an axial opening that intersect one another, wherein the staple is configured to extend through the transverse aperture, and wherein the set screw is configured to be advanced into the sleeve along the axial opening.

Paragraph 38 the system of paragraph 36 or 37, wherein the set screw is configured to be disposed in threaded engagement with the sleeve and to be advanced against the nail until the nail is cooperatively clamped by the sleeve and the set screw.

Paragraph 39 the system of paragraph 38, wherein at least one of the sleeve and the set screw has a projection configured to contact and deform a surface region of the nail when the set screw is tightened against the nail.

Paragraph 40. the system of paragraph 39, wherein at least one of the sleeve and the set screw having the protruding portion comprises a harder material than the nail.

Paragraph 41. the system of paragraph 39 or 40, wherein the set screw has a projection configured to contact and deform a surface region of the nail, and wherein the projection of the set screw projects distally from an axis of the set screw and forms a distal edge of the set screw.

Paragraph 42 the system of paragraph 41, wherein the distal edge is annular.

Paragraph 43 the system of any of paragraphs 39 to 42, wherein the sleeve has a protruding portion configured to contact and deform a surface area of the nail, and wherein the protruding portion of the sleeve is positioned in the transverse aperture of the sleeve.

Paragraph 44 the system of any of paragraphs 36 to 43, wherein the external thread of the set screw is configured to deform the sleeve to create a distal extension of the internal thread in the sleeve.

Paragraph 45. the system of paragraph 44, wherein the set screw comprises a harder material than the sleeve.

Paragraph 46. the system of paragraph 45, wherein each of the sleeve and the set screw comprises a metal alloy, and wherein the metal alloy of the set screw is harder than the metal alloy of the sleeve.

Paragraph 47. the system of paragraph 46, wherein the set screw comprises a cobalt chromium alloy, and wherein the sleeve comprises a titanium alloy.

Paragraph 48 the system of any of paragraphs 44 to 47, wherein the external thread of the set screw has a greater axial length than the internal thread of the sleeve prior to creating the distal extension of the internal thread.

Paragraph 49 the system of any of paragraphs 1 to 48, wherein the anterior region of the staple is configured to extend through the transverse aperture of the cannula, wherein the anterior region of the staple has an elongate main portion and a distal tip, and wherein the distal tip is radially offset from the main portion.

Paragraph 50 the system of paragraph 49, wherein the central axis of the distal tip is substantially parallel to and offset from the longitudinal axis of the main portion.

Paragraph 51 the system of paragraph 49 or 50, wherein the main portion has a uniform diameter, and wherein the end is tapered.

Paragraph 52 the system of any of paragraphs 49 to 51, wherein the tail region of the staple is curved in the staple plane, and wherein the tip is offset from the main portion in the staple plane.

Paragraph 53 the system of any of paragraphs 49 to 52, wherein the terminus is less than half the length of the main portion.

Paragraph 54 the system of any of paragraphs 1 to 53, wherein the guide axis is movable relative to the bone while the instrument remains coupled to the bone to change the transverse position of the guide axis relative to the bone, wherein optionally the guide axis is movable while the bone remains clamped by the instrument and/or remains coupled to the bone with one or more wire members, wherein optionally the guide axis is movable from a first position to at least one second position in which the guide axis is parallel to its orientation in the first position, and wherein optionally the guide axis is defined by a guide portion that is rotatable to move the guide axis.

Paragraph 55 the system of any of paragraphs 1 to 54, further comprising any or a combination of the definitions of examples 4 and 6.

Example 6.Alternative embodiment III

This section describes still further alternative embodiments of the present disclosure as a series of indexed paragraphs.

Paragraph 1. a method of fixing a bone, the method comprising: (A) selecting an instrument comprising a pair of jaws and a guide portion defining a guide axis, the guide portion having a self-centering configuration wherein the guide axis continues to lie in a central plane positioned between and equidistant from the jaws as the jaws are opened and closed; (B) engaging the long bone with the jaws such that the guide axis extends across the bone; (C) drilling a hole in the bone along a guide axis; (D) placing a cannula at least partially into a hole in a bone; (E) advancing the nail along the medullary canal of the bone such that the nail extends through the cannula; and (F) locking the staple to the sleeve.

Paragraph 2 the method of paragraph 1, wherein the step of drilling a hole includes drilling a wider hole in the near cortex of the bone along the guide axis and drilling a cylindrical narrower hole in the far cortex of the bone along the guide axis, and wherein the step of placing includes placing the tail portion of the cannula in the wider hole and placing the front portion of the cannula in the narrower hole.

Paragraph 3 the method of paragraph 1 or paragraph 2, wherein the step of placing the sleeve includes placing the sleeve into threaded engagement with the bone at the hole.

Paragraph 4 the method of any one of paragraphs 1 to 3, wherein the step of locking comprises clamping the nail in cooperation with the sleeve and the set screw.

Paragraph 5 the method of any one of paragraphs 1 to 4, wherein the sleeve defines a transverse aperture and an axial opening that intersect one another, wherein the step of advancing the nail comprises passing a leading end of the nail through the transverse aperture, and wherein the step of locking comprises advancing a set screw into the sleeve along the axial opening.

Paragraph 6 the method of any one of paragraphs 1 to 5, wherein the step of placing comprises passing the cannula through a guide portion of the instrument along a guide axis.

Paragraph 7 the method of any of paragraphs 1 to 6, wherein the cannula includes a body forming a shoulder, and further includes a post projecting distally from the shoulder, and wherein the step of placing the cannula includes advancing the cannula into the bone until contact between the shoulder of the cannula and a distal cortex of the bone prevents further advancement.

Paragraph 8 the method of any of paragraphs 1 to 7, further comprising moving the guide portion relative to the jaws while the jaws remain engaged with the bone to offset the guide axis from the central plane.

Paragraph 9 the method of paragraph 8, wherein the step of drilling the hole is performed along a guide axis, wherein the guide axis is offset from the central plane.

Paragraph 10 the method of paragraph 8 or paragraph 9, wherein the step of moving the guide portion comprises rotating the guide portion relative to the jaws about an axis parallel to but offset from the guide axis.

Paragraph 11 the method of any of paragraphs 1 to 10, further comprising the step of driving a pair of wire members from the instrument into the bone on non-parallel trajectories defined by the instrument such that each wire member couples the instrument to the bone.

Paragraph 12. the method of paragraph 11, wherein the step of driving a pair of wire members includes passing a leading end of each wire member through a respective wire receiving channel defined by the instrument and through the bone.

Paragraph 13. a method of fixing bone, the method comprising: (A) engaging an opposite side of a long bone with a jaw of an instrument having a guide portion coupled to the jaw and defining a guide axis extending across the bone; (B) coupling the instrument to the bone with a pair of wire members driven into the bone on non-parallel trajectories defined by the instrument; (C) drilling a hole in the bone along a guide axis; (D) placing a cannula at least partially into a hole in a bone; (E) advancing the nail along the medullary canal of the bone such that the nail extends through the cannula; and (F) locking the staple to the sleeve.

Paragraph 14. the method of paragraph 13, wherein the step of coupling the instrument includes passing the leading end of each wire member through a wire-receiving channel of the instrument, and wherein the wire-receiving channels define one of the non-parallel trajectories.

Paragraph 15 the method of paragraph 14, wherein the step of coupling the instrument includes passing the leading end of the wire member through the bone.

Paragraph 16 the method of paragraph 14 or paragraph 15, wherein the instrument includes a pair of levers pivotally connected to each other and forming a jaw, wherein the guide portion is connected to the levers via a retainer, and wherein the retainer defines each wire receiving channel.

Paragraph 17. the method of paragraph 16, wherein the retainer is in contact with the bone when the step of coupling has been completed.

Paragraph 18. the method of any of paragraphs 13 to 17, wherein the step of coupling the instrument disposes each wire member extending through a respective wire-receiving channel of the instrument and through the bone.

Paragraph 19 the method of any of paragraphs 13 to 18, wherein the step of coupling arranges the wire members on non-parallel trajectories that are closest to each other before reaching the bone from the instrument.

Paragraph 20 the method of any of paragraphs 13 to 19, wherein each trajectory avoids the medullary canal of the bone.

Paragraph 21 the method of any one of paragraphs 13 to 20, wherein each wire member is a k-wire.

Paragraph 22. a system for bone fixation, the system comprising: (A) a cannula configured for placement across a medullary canal of a long bone, the cannula including a body having an external threaded configuration and defining a transverse aperture, and a post projecting from a shoulder formed by a leading end region of the body; (B) a nail configured to be placed along a medullary canal of a bone such that the nail extends through the transverse aperture of the cannula; and (C) a set screw configured to be advanced into the sleeve and against the nail such that the set screw and the sleeve cooperatively clamp the nail.

Paragraph 23. the system of paragraph 22, wherein at least one of the sleeve and the set screw has a projection configured to contact and deform a surface region of the nail when the set screw is advanced into the sleeve and against the nail.

Paragraph 24 the system of paragraph 23, wherein at least one of the sleeve and the set screw having the protruding portion comprises a harder material than the nail.

Paragraph 25, the system of paragraph 23 or paragraph 24, wherein the set screw has a projection configured to contact and deform a surface region of the nail, and wherein the projection of the set screw projects distally from an axis of the set screw and forms a distal edge of the set screw.

Paragraph 26 the system of paragraph 25, wherein the distal edge is annular.

Paragraph 27 the system of any of paragraphs 23 to 26, wherein the sleeve has a projection configured to contact and deform a surface area of the staple, and wherein the projection of the sleeve is formed by a wall of the transverse aperture.

Paragraph 28 the system of any of paragraphs 22 to 27, wherein the set screw comprises a harder material than the sleeve, wherein the set screw has an external thread that is complementary to the internal thread of the sleeve, and wherein the external thread of the set screw is configured to form a distal extension of the internal thread of the sleeve when the set screw is advanced into the sleeve and against the nail.

Paragraph 29 the system of paragraph 28, wherein the set screw comprises a harder metal alloy, and wherein the sleeve comprises a softer metal alloy.

Paragraph 30 the system of paragraph 29, wherein the harder metal alloy is a cobalt chromium alloy, and wherein the softer metal alloy is a titanium alloy.

Paragraph 31 the system of any of paragraphs 22 to 30, wherein the column is cylindrical.

Paragraph 32 the system of any of paragraphs 22 to 31, wherein the shoulder has a circular profile resulting from a proximal to distal reduction in diameter of the leading end region of the body.

Paragraph 33 the system of any of paragraphs 22 to 32, wherein the sleeve defines a long axis, and wherein the transverse aperture is elongated parallel to the long axis and has an oblique entrance.

Paragraph 34. a method of fixing bone, the method comprising: (A) drilling a wider hole through the near cortex of the long bone and a narrower hole in the far cortex of the bone; (B) selecting a sleeve having a body with a diameter corresponding to the wider bore and a post with a diameter corresponding to the narrower bore, the post projecting from a shoulder formed by a front end region of the body; (C) driving the cannula into the wider bore and the narrower bore until contact between the shoulder and the far cortex of the bone prevents further advancement of the cannula; (D) advancing the nail along the medullary canal such that the nail extends through the cannula; and (E) locking the nail to the sleeve.

Paragraph 35 the method of paragraph 34, wherein each of the wider aperture and the narrower aperture is cylindrical.

Paragraph 36 the method of paragraph 34 or paragraph 35, wherein the steps of drilling are performed with a first drill to form a wider hole and with a second drill to form a narrower hole.

Paragraph 37 the method of any of paragraphs 34 to 36, wherein the step of drilling comprises forming a recessed region in the far cortex of the bone, and wherein the recessed region is complementary to the shoulder of the cannula.

Paragraph 38 the method of any of paragraphs 34 to 37, wherein the step of driving disposes the sleeve into threaded engagement with the bone.

Paragraph 39 the method of any of paragraphs 34 to 38, wherein the step of locking the nail comprises the step of clamping an axial region of the nail between the sleeve and the set screw.

Paragraph 40. the method of paragraph 39, wherein the sleeve has an internal thread complementary to the external thread of the sleeve, the method further comprising the step of forming a distal extension of the internal thread of the sleeve using the external thread of the set screw.

Paragraph 41. the method of paragraph 40, wherein the set screw is formed of a harder material than the sleeve.

Paragraph 42 the method of paragraph 41, wherein the set screw is formed of a cobalt chromium alloy, and wherein the sleeve is formed of a titanium alloy.

Paragraph 43. a method of fixing a bone, the method comprising: (A) engaging a bone with a jaw of an instrument having a guide portion, the guide portion coupled to the jaw and defining a guide axis extending across the bone; (B) placing a nail or reamer along the medullary canal of the bone; (C) determining the extent to which the nail or reamer and the guide portion are aligned with one another by fluoroscopy; (D) if the degree of alignment is not sufficient, repositioning the guide axis by moving the guide portion relative to the jaws while the jaws remain engaged with the bone to improve the degree of alignment; (E) retracting the nail or reamer; (F) drilling a hole in the bone from the guide portion along the guide axis; (G) placing a cannula at least partially into a hole in a bone; (H) advancing the nail along the medullary canal such that the nail extends through the cannula; and (I) locking the nail to the sleeve.

Paragraph 44. the method of paragraph 43, wherein the step of placing the sleeve includes passing the sleeve through the guide portion along the guide axis.

Paragraph 45. a system for bone fixation, the system comprising: (A) a cannula configured to be positioned in the bone bi-cortical, transverse to a medullary canal of the bone, the cannula defining an axial opening intersecting the transverse aperture; (B) a nail having a leading region and a trailing region, the nail configured to be placed along the medullary canal such that the leading region of the nail extends through the transverse aperture, the trailing region defining one or more openings configured to receive fasteners that attach the trailing region to the bone; and (C) a locking member configured to be threaded into the axial opening of the sleeve and advanced against the staple to lock the forward region of the staple to the sleeve; wherein the anterior region of the staple has an elongate main portion and a distal tip, and wherein the tip is radially offset from the main portion.

Paragraph 46. the system of paragraph 45, wherein the central axis of the tip is substantially parallel to and offset from the longitudinal axis of the main portion.

Paragraph 47 the system of paragraph 45 or paragraph 46, wherein the main portion has a uniform diameter, and wherein the end is tapered.

Paragraph 48 the system of any of paragraphs 45 to 47, wherein the tail region is curved in a plane, and wherein the tip is offset from the main portion in said plane.

Paragraph 49 the system of any of paragraphs 45 to 48, wherein the terminus is less than half the length of the main portion.

Paragraph 50. a method of fixing a bone, the method comprising: (A) placing a cannula at least partially into the bone such that the cannula transversely spans a medullary canal of the bone, the cannula defining an axial opening intersecting the transverse aperture; (B) selecting a staple comprising a leading region and a trailing region, the leading region having a main portion and a tip, the tip being radially offset from a longitudinal axis of the main portion; (C) advancing the tip along a medullary canal of the bone until the tip is proximate the transverse portal; (D) rotating the spike about the long axis, if necessary, to improve alignment of the tip with the transverse aperture; (5) passing the tip through the transverse aperture; (F) locking the front region of the nail to the sleeve using a locking member received in the axial opening of the sleeve; and (G) attaching the tail region of the nail to the bone.

Paragraph 51. a system for bone fixation, the system comprising: (A) a nail configured to be placed along a medullary canal of a bone; (B) a cannula having an external threaded configuration to engage bone, the cannula defining a transverse aperture through which a nail is configured to extend, and the cannula further defining an axial opening having an internal thread; and (C) a set screw having an external thread configured to be disposed in threaded engagement with the internal thread of the sleeve and advanced while in threaded engagement until the nail is cooperatively clamped by the sleeve and the set screw; wherein the set screw has an interference fit in the sleeve such that advancement of the set screw forms an internally threaded distal extension at the axial opening of the sleeve.

Paragraph 52. the system of paragraph 51, wherein the set screw comprises a harder material than the sleeve.

Paragraph 53. the system of paragraph 52, wherein the set screw comprises a cobalt chromium alloy, and wherein the sleeve comprises a titanium alloy.

Paragraph 54 the system of any of paragraphs 51 to 53, wherein the external thread of the set screw has a greater axial length than the internal thread of the sleeve.

The disclosure set forth above may encompass a variety of different inventions with independent utility. While each of these inventions has been disclosed in its preferred form, the specific embodiments thereof as disclosed and illustrated herein are not to be considered in a limiting sense as numerous variations are possible. The subject matter of the inventions includes all novel and non-obvious combinations and subcombinations of the various elements, features, functions and/or properties disclosed herein. The following claims particularly point out certain combinations and subcombinations regarded as novel and nonobvious. Inventions embodied in other combinations and subcombinations of features, functions, elements and/or properties may be claimed in applications claiming priority from this or a related application. Such claims, whether directed to a different invention or directed to the same invention, and whether broader, narrower, equal, or different in scope to the original claims, also are regarded as included within the subject matter of the inventions of the present disclosure. In addition, a sequence indicator (e.g., first, second, or third) for identifying an element is used to distinguish between the elements, and unless otherwise specifically stated, the sequence indicator cannot indicate a particular position or order of such elements. Finally, the present disclosure incorporates material by reference. If any ambiguity or conflict in meaning of a term arises through this incorporation by reference, the text of this application governs the interpretation of that term.

Claims (54)

1. A system for bone fixation, the system comprising:

an instrument defining a guide axis and configured to be coupled to a bone such that the guide axis extends across the bone;

a cannula configured to be placed at least partially into at least one hole drilled in the bone along the guide axis;

a nail configured to be placed along a medullary canal of a bone such that the nail extends through the cannula; and

a locking member configured to lock the staple to the sleeve.

2. The system of claim 1, wherein the instrument comprises a guide portion and a pair of jaws, wherein the guide portion defines the guide axis, and wherein the jaws are coupled to the guide portion and configured to engage a bone such that the instrument is coupled to the bone.

3. The system of claim 2, wherein the guide axis continues to lie in a central plane positioned between and equidistant from the jaws as the jaws open and close.

4. A system according to claim 3, wherein the jaws are movable relative to each other about a pivot axis located in the central plane.

5. The system of claim 3, wherein the instrument has a pair of levers pivotally connected to each other, wherein the guide portion is coupled to the pair of levers via a holder for the guide portion, wherein the levers are coupled to the holder by respective link members having pivotable connections to each other, and wherein the pivotable connections of the link members move along slots defined by the holder as the jaws open and close, thereby ensuring that the guide portion remains equidistant from the jaws regardless of the degree to which the jaws are open.

6. The system of claim 2, wherein the guide portion is configured to be movable from a first position to at least one second position while the jaws remain engaged with bone, wherein the guide portion is coupled to the jaws in each of the first and second positions, wherein the guide axis in the first position of the guide portion lies within a central plane between the jaws, and wherein the guide axis in each second position of the guide portion is parallel to but offset from the central plane and the guide axis in the first position of the guide portion.

7. The system of claim 6, wherein the guide portion is configured to be movable from the first position to each second position while the guide portion remains coupled to the jaw.

8. The system of claim 6, wherein the guide portion is movable to at least one third position, and wherein the guide axis in each second position of the guide portion and the guide axis in each third position of the guide portion are parallel to each other, but offset from the central plane in opposite directions.

9. The system of claim 6, wherein the guide portion is movable to produce a plurality of offsets of the guide axis from the central plane, wherein the guide portion is coupled to the jaw via a retainer, and wherein the plurality of offsets are predefined by features of the guide portion and the retainer that are complementary to one another.

10. The system of claim 9, wherein the plurality of offsets includes predetermined offsets of one and two millimeters from the central plane.

11. The system of claim 6, wherein the instrument has a gauge to indicate a current offset of the guide axis from the central plane.

12. The system of claim 6, wherein the guide portion is configured to rotate relative to the jaw about an axis parallel to but spaced from the guide axis to move the guide portion from the first position to each second position.

13. The system of claim 1, wherein the instrument is at least predominantly radiolucent.

14. The system of claim 13, wherein the instrument has a guide portion defining the guide axis, and wherein the guide portion includes a radiopaque member centered on the guide axis.

15. The system of claim 14, wherein the radiopaque member is a radiopaque ring, and wherein the guide portion comprises a pair of radiopaque rings each centered on and spaced apart from each other along the guide axis.

16. The system of claim 1, wherein the instrument defines a wire receiving channel configured to guide a wire member into a bone to couple the instrument to the bone with the wire member.

17. The system of claim 16, wherein the instrument defines a pair of wire receiving channels configured to guide a pair of wire members into the bone on non-parallel trajectories to couple the instrument to the bone with each of the wire members.

18. The system of claim 16, wherein the wire-receiving channel is configured to guide a wire member through the bone on a trajectory that avoids a space in the medullary canal to be occupied by the nail.

19. The system of claim 16, wherein the instrument comprises a pair of levers pivotally connected to each other, wherein each lever provides one of the jaws, wherein the guide portion is connected to the lever via a retainer for the guide portion, wherein the retainer defines the wire receiving channel, and wherein optionally a distal end of the guide portion is flush with a distal end of the retainer.

20. The system of claim 19, wherein the retainer has a proximal surface area facing away from the distal end of the retainer, and wherein each wire-receiving channel extends through the retainer from the proximal surface area of the retainer to the distal end of the retainer.

21. The system of claim 19, wherein the retainer surrounds at least an axial region of the guide portion.

22. The system of claim 17, wherein the pair of wire receiving channels are configured such that the non-parallel trajectories are closest to each other before reaching a bone from the instrument.

23. The system of claim 22, wherein the pair of wire-receiving channels are configured such that the non-parallel trajectories are closest to each other inside the instrument.

24. The system of claim 16, further comprising the wire member, wherein the wire member is a k-wire.

25. The system of claim 1, wherein the at least one hole comprises a wider hole and a narrower hole, the system further comprising one or more drills configured to drill the wider hole along the guide axis in a near cortex of a bone and drill the narrower hole along the guide axis in a far cortex of a bone, the cannula comprising a tail portion having a diameter corresponding to the wider hole and a front portion having a diameter corresponding to the narrower hole.

26. The system of claim 25, wherein the one or more drills include a first drill that drills the wider hole and a second drill that drills the narrower hole.

27. The system of claim 26, wherein the first drill includes a drilling portion to drill the wider hole, and further comprising a stop member configured to contact the instrument to prevent the drilling portion from advancing axially to a far cortex of a bone.

28. The system of claim 26, wherein the second drill includes a drilling portion to drill the narrower hole and a reaming portion to enlarge a region of the medullary canal adjacent to the narrower hole.

29. The system of claim 1, wherein the cannula has an external thread configuration to engage bone at an aperture in the at least one aperture.

30. The system of claim 1, wherein the cannula is configured to be advanced along the guide axis through a guide portion of the instrument and into a bone.

31. The system of claim 1, wherein the cannula includes a body having a shoulder, and further comprising a post projecting distally from the shoulder.

32. The system of claim 31, wherein the shoulder has a rounded profile resulting from a proximal-to-distal reduction in diameter of a leading end region of the body.

33. The system of claim 31, wherein the column is cylindrical.

34. The system of claim 1, wherein the cannula defines a long axis and further defines a transverse aperture through which the spike is configured to extend, and wherein the transverse aperture is elongated parallel to the long axis of the cannula.

35. The system of claim 34, wherein the transverse aperture has a slanted entrance.

36. The system of claim 1, wherein the locking member comprises a set screw having external threads complementary to internal threads of the sleeve.

37. The system of claim 36, wherein the cannula defines a transverse aperture and an axial opening that intersect one another, wherein the nail is configured to extend through the transverse aperture, and wherein the set screw is configured to be advanced into the cannula along the axial opening.

38. The system of claim 36, wherein the set screw is configured to be disposed in threaded engagement with the sleeve and advanced against the nail until the nail is cooperatively clamped by the sleeve and the set screw.

39. The system of claim 38, wherein at least one of the sleeve and the set screw has a protruding portion configured to contact and deform a surface region of the nail when the set screw is tightened against the nail.

40. The system of claim 39, wherein the at least one of the sleeve and the set screw having the protruding portion comprises a harder material than the nail.

41. The system of claim 39, wherein the set screw has a protruding portion configured to contact and deform a surface area of the nail, and wherein the protruding portion of the set screw protrudes distally from an axis of the set screw and forms a distal edge of the set screw.

42. The system of claim 41, wherein the distal edge is annular.

43. The system of claim 39, wherein the sleeve has a protruding portion configured to contact and deform a surface region of the staple, and wherein the protruding portion of the sleeve is positioned in a transverse aperture of the sleeve.

44. The system of claim 36, wherein the external threads of the set screw are configured to deform the sleeve to create a distal extension of the internal threads in the sleeve.

45. The system of claim 44, wherein the set screw comprises a harder material than the cannula.

46. The system of claim 45, wherein each of the bushing and the set screw comprises a metal alloy, and wherein the metal alloy of the set screw is harder than the metal alloy of the bushing.

47. The system of claim 46, wherein the set screw comprises a cobalt chromium alloy, and wherein the sleeve comprises a titanium alloy.

48. The system of claim 44, wherein the external thread of the set screw has a greater axial length than the internal thread of the sleeve prior to creating the distal extension of the internal thread.

49. The system of claim 1, wherein a forward region of the staple is configured to extend through a transverse aperture of the cannula, wherein the forward region of the staple has an elongate main portion and a distal tip, and wherein the distal tip is radially offset from the main portion.

50. The system of claim 49, wherein a central axis of the distal tip is substantially parallel to and offset from a longitudinal axis of the main portion.

51. The system of claim 49, wherein the main portion has a uniform diameter, and wherein the tip is tapered.

52. The system of claim 49, wherein a tail region of the staple is curved in a staple plane, and wherein the tip is radially offset from the main portion in the staple plane.

53. The system of claim 49, wherein the terminal end is less than half of the length of the main portion.

54. A system for bone fixation, the system comprising:

a cannula configured for placement across a medullary canal of a long bone, the cannula including a body having an external threaded configuration and defining a transverse aperture, and a post projecting from a shoulder provided by a leading end region of the body;

a nail configured to be placed along a medullary canal of a bone such that the nail extends through the transverse aperture of the cannula; and

a set screw configured to be advanced into the sleeve and against the nail such that the set screw and the sleeve cooperatively clamp the nail.

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